Trials (Centre Henri Becquerel)
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NCTID: NCT04712097
Title: A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma Study Summary: This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy. Sponsor: Hoffmann-La Roche Intervention: Mosunetuzumab Start Date: 2021-10-27 Last Updated: 2023-11-03 Number of Patients: 474 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Follicular Lymphoma
NCTID: NCT04052997
Title: Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma Study Summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL). Sponsor: ADC Therapeutics S.A. Intervention: Camidanlumab Tesirine Start Date: 2019-09-13 Last Updated: 2023-03-31 Number of Patients: 117 Recruitment Status: COMPLETED Condition: Relapsed Hodgkin Lymphoma
NCTID: NCT00875667
Title: A Study to Determine the Efficacy of Lenalidomide Versus Investigator’s Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) Study Summary: To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2009-04-30 Last Updated: 2019-09-16 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT00636467
Title: Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm Study Summary: The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection). Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month. The number of patients required in this multicentric and prospective study is 240 (16 participating centers). Sponsor: Centre Leon Berard Intervention: No name Start Date: 2008-03 Last Updated: 2012-09-26 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01305122
Title: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma Study Summary: This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years. * cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy) * cohort B: patients with disease simple monitoring. The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests. Sponsor: Centre Leon Berard Intervention: neurocognitive tests Start Date: 2011-02 Last Updated: 2021-02-09 Number of Patients: 112 Recruitment Status: TERMINATED Condition: OMS Grade II Glioma
NCTID: NCT01583322
Title: Vargatef in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Ovarian Cancer Study Summary: Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy. In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing. Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib). This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib). Sponsor: ARCAGY/ GINECO GROUP Intervention: vargatef Start Date: 2012-06 Last Updated: 2023-09-06 Number of Patients: 188 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT03784014
Title: Molecular Profiling of Advanced Soft-tissue Sarcomas Study Summary: MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays. In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq <math display="block">NGS</math>) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant’s tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial. Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Intervention: Nilotinib Start Date: 2019-10-19 Last Updated: 2022-10-05 Number of Patients: 960 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT04053322
Title: Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. Study Summary: This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations or alterations of genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI) status. Sponsor: UNICANCER Intervention: Durvalumab Start Date: 2019-08-26 Last Updated: 2023-11-07 Number of Patients: 172 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer
NCTID: NCT01553786
Title: Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL) Study Summary: This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient. Sponsor: The Lymphoma Academic Research Organisation Intervention: Lenalidomide Start Date: 2011-11 Last Updated: 2021-07-26 Number of Patients: 80 Recruitment Status: COMPLETED Condition: T-cell Lymphoma
NCTID: NCT01874587
Title: Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma Study Summary: The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one “standard” arm based on the use of a single pre-treatment planning and one “experimental” arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed. Sponsor: Center Eugene Marquis Intervention: adaptative radiotherapy Start Date: 2013-07 Last Updated: 2021-07-27 Number of Patients: 132 Recruitment Status: COMPLETED Condition: Oropharynx Cancer
NCTID: NCT00283985
Title: Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma Study Summary: Nasal
asal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin’s lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples. The investigators propose a phase II protocol for patients with refractory or relapsing nasal asal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy. Since january 2009, the study concerns all patients with nasal asal type NK-T-cell lymphoma who have not received asparaginase before.
Sponsor: University Hospital, Limoges Intervention: Kidrolase Start Date: 2006-02 Last Updated: 2013-02-28 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT00866047
Title: A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma Study Summary: This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2009-03 Last Updated: 2017-03-22 Number of Patients: 58 Recruitment Status: COMPLETED Condition: Lymphoma, Large-Cell, Anaplastic
NCTID: NCT01528085
Title: Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Study Summary: The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations. Sponsor: Goethe University Intervention: Nilotinib Start Date: 2012-01 Last Updated: 2020-07-30 Number of Patients: 79 Recruitment Status: COMPLETED Condition: Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia
NCTID: NCT04703686
Title: Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy Study Summary: This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy: * cohort 1: DLBCL patients * cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial. Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab. The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy Sponsor: The Lymphoma Academic Research Organisation Intervention: Obinutuzumab Start Date: 2021-03-30 Last Updated: 2023-09-26 Number of Patients: 67 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-Cell Lymphoma Refractory
NCTID: NCT04115007
Title: Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients Study Summary: INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study. PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients. Sponsor: UNICANCER Intervention: Stereotactic Body Radiotherapy (SBRT) + Standard of care Start Date: 2020-06-23 Last Updated: 2023-02-17 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Oligometastatic Hormone Sensitive Prostate Cancer
NCTID: NCT02298283
Title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD Study Summary: This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine). Sponsor: The Lymphoma Academic Research Organisation Intervention: brentuximab vedotin Start Date: 2015-04 Last Updated: 2021-07-26 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT03339843
Title: Multiorgan Metabolic Imaging Response Assessment of Abemaciclib Study Summary: Open-label, phase II, basket trial. This trial is a screening program for abemaciclib efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and RECIST v1.1 criteria. Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary stage: # Platinum-refractory esophageal adenocarcinoma (ADC) # Platinum-refractory esophageal squamous cell carcinoma (SCC) # Platinum-refractory cholangiocarcinoma # Platinum-refractory and progressive after immunotherapy urothelial cancer # Platinum-refractory endometrial cancer Sponsor: Jules Bordet Institute Intervention: Abemaciclib Start Date: 2018-12-19 Last Updated: 2023-07-10 Number of Patients: 85 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Esophageal Adenocarcinoma
NCTID: NCT02095743
Title: Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer Study Summary: Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients. The aim of this study is to prospectively compare the patients’ satisfaction and tolerance of each of the two devices. Sponsor: Centre Henri Becquerel Intervention: implanted port for chemo administration (X-port isp) Start Date: 2014-04 Last Updated: 2018-07-24 Number of Patients: 256 Recruitment Status: UNKNOWN Condition: Early Stage Breast Carcinoma
NCTID: NCT01900743
Title: Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma Study Summary: This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline). Five cohorts will be defined: Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups. Sponsor: Centre Oscar Lambret Intervention: Regorafenib Start Date: 2013-06-05 Last Updated: 2021-04-09 Number of Patients: 219 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT03336333
Title: A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL Study Summary: To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-10-31 Last Updated: 2023-11-09 Number of Patients: 590 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02867033
Title: National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES) Study Summary: The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort. Sponsor: Centre Oscar Lambret Intervention: biopsy Start Date: 2016-03-22 Last Updated: 2023-02-08 Number of Patients: 628 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Aggressive Fibromatosis
NCTID: NCT02473133
Title: Study of Interest of Personalized Radiotherapy Dose Redistribution in Patients With Stage III NSCLC Study Summary: In patients with locally advanced stage III non-small cell lung cancer, the probability of local control remains low (about 17% at 1 year). Concomitant radio-chemotherapy is the standard treatment. An increase in total radiotherapy dose (from 66 to 74 Gray) has been proposed to improve local control, with contradictory results. Relevant FDG-PET scan images can be acquired during radio-chemotherapy, with a demonstrated prognostic impact and recently in a multicentre prospective study. A significant reduction in FDG uptake / volume (metabolic response) suggests that the radiotherapy target volume could be reduced during radiotherapy possibly improving organs at risk tolerance. Conversely, a lack of metabolic response may justify treatment intensification before the end of radiotherapy. The investigators hypothesis is to investigate the individual tumour heterogeneity on FDG-PET during radio-chemotherapy to reduce the volume to a biological target that could receive a higher total dose (personalized dose redistribution). Sponsor: Centre Henri Becquerel Intervention: Personalized dose redistribution Start Date: 2015-07 Last Updated: 2016-07-28 Number of Patients: 150 Recruitment Status: UNKNOWN Condition: Non-small Cell Lung Cancer
NCTID: NCT01247233
Title: Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer Study Summary: The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management. In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs. Sponsor: UNICANCER Intervention: Whole Breast Irradiation + Boost or Hypofractionated irradiation Start Date: 2010-12-27 Last Updated: 2023-03-01 Number of Patients: 1006 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03625037
Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Study Summary: The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human (FIH)) * an expansion part (Phase 2a) * a dose-optimization part (Phase 2a) Sponsor: Genmab Intervention: Epcoritamab Start Date: 2018-06-26 Last Updated: 2023-08-08 Number of Patients: 786 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: NCT02541383
Title: A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma Study Summary: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma. Sponsor: Intergroupe Francophone du Myelome Intervention: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) Start Date: 2015-09 Last Updated: 2020-12-07 Number of Patients: 1085 Recruitment Status: UNKNOWN Condition: Multiple Myeloma
NCTID: NCT00005583
Title: Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer. Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit Intervention: cisplatin Start Date: 2000-01 Last Updated: 2013-08-02 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT02815137
Title: Detection and Prognostic Value of Recurrent XPO1 Mutations of Patients With Classical Hodgkin Lymphoma Study Summary: The purpose of this study is to determine if the XPO1 E571K mutation could be used as molecular residual disease biomarker in classical Hodgkin’s lymphoma. To determine the interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax determined by Positron Emission Tomography after C2 and at end of treatment. Sponsor: Centre Henri Becquerel Intervention: Digital Polymerase Chain Reaction Start Date: 2016-06-01 Last Updated: 2018-07-23 Number of Patients: 130 Recruitment Status: UNKNOWN Condition: Classical Hodgkin Lymphoma
NCTID: NCT04144387
Title: Evaluation of the Impact of the Update SMM Criteria on the Natural History of SMM to Establish New Recommendations. Study Summary: This study is a prospective open label interventional multicenter study evaluating the impact of the update multiple myeloma criteria on the natural history of smoldering myeloma in order to establish new recommendations about follow up and prognostic evaluation of smoldering myeloma. Sponsor: Intergroupe Francophone du Myelome Intervention: Myelogram Start Date: 2020-02-11 Last Updated: 2022-08-10 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Smoldering Multiple Myeloma
NCTID: NCT05355987
Title: Impact of Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma Study Summary: Multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. Although treatment improved in the last years, the patients’ prognostic is associated with cytogenetic abnormalities. Oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. It contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers’. The aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis. Sponsor: Centre Henri Becquerel Intervention: Early oncological supportive care Start Date: 2022-06-03 Last Updated: 2022-12-23 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT06056414
Title: Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation Study Summary: Performing a breast macrobiopsy can be extremely delicate and anxiety-provoking. It can have an impact on the course of future examinations. Patients’ emotional feelings also have a definite impact on the nursing staff. The purpose of the MBRESC study is to evaluate Energy Resonance by Cutaneous Stimulation , a manual acupressure technique, in the management of anxiety prior to breast macrobiopsy. Sponsor: Centre Henri Becquerel Intervention: Energy Resonance by Cutaneous Stimulation Start Date: 2023-10-02 Last Updated: 2023-10-10 Number of Patients: 57 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Neoplasm
NCTID: NCT01241500
Title: Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts Study Summary: The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients. Sponsor: Onconova Therapeutics, Inc. Intervention: ON 01910.Na Start Date: 2010-11 Last Updated: 2020-06-30 Number of Patients: 299 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT03951337
Title: 64Cu-ATSM PET/CT in Rectum Cancer (TEP 64Cu-ATSM-Rectum) Study Summary: This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced Sponsor: Institut Cancerologie de l’Ouest Intervention: 64Cu-ATSM Start Date: 2019-04-26 Last Updated: 2022-08-30 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Rectal Cancer
NCTID: NCT01272037
Title: Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Study Summary: This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Estrogen can cause the growth of breast cancer cells. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. Sponsor: National Cancer Institute (NCI) Intervention: Anastrozole Start Date: 2011-01-15 Last Updated: 2023-11-14 Number of Patients: 5018 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Ductal Carcinoma In Situ
NCTID: NCT02542514
Title: Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma Study Summary: The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria. Sponsor: The Lymphoma Academic Research Organisation Intervention: Ibrutinib Start Date: 2015-09 Last Updated: 2022-04-14 Number of Patients: 52 Recruitment Status: COMPLETED Condition: Primary Central Nervous Lymphoma
NCTID: NCT00553943
Title: Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis Study Summary: The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: * before cerebral radiotherapy for PCL * after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity Sponsor: Lymphoma Study Association Intervention: Rituximab Start Date: 2007-07 Last Updated: 2018-08-23 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT00144807
Title: ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma Study Summary: This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2003-12 Last Updated: 2015-09-02 Number of Patients: 128 Recruitment Status: COMPLETED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT01941407
Title: First Line Metastatic Breast Cancer Treatment (ESMERALDA) Study Summary: The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities. It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer. Sponsor: ARCAGY/ GINECO GROUP Intervention: Eribulin Start Date: 2013-11 Last Updated: 2016-03-17 Number of Patients: 61 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT02393287
Title: Retroprospective Real Life Observatory of Eribulin Study Summary: The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period. Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug. Sponsor: Institut Cancerologie de l’Ouest Intervention: Eribulin (ReProLine) Start Date: 2014-11 Last Updated: 2019-05-09 Number of Patients: 753 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT02947685
Title: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Study Summary: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer. Sponsor: Alliance Foundation Trials, LLC. Intervention: palbociclib Start Date: 2017-06-21 Last Updated: 2023-05-30 Number of Patients: 496 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: HER-2 Positive Breast Cancer
NCTID: NCT04984837
Title: Study of Lacutamab in Peripheral T-cell Lymphoma Study Summary: This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL). The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1). Sponsor: The Lymphoma Academic Research Organisation Intervention: Lacutamab Start Date: 2021-10-05 Last Updated: 2022-08-19 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT01358747
Title: Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL Study Summary: All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result. Sponsor: Centre Hospitalier Universitaire Dijon Intervention: BEACOPPesc Start Date: 2011-05 Last Updated: 2014-05-21 Number of Patients: NA Recruitment Status: COMPLETED Condition: Hodgkin’s Lymphoma
NCTID: NCT05102747
Title: Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (310 Gy) to the Historical Single-dose Radiosurgery (120 to 25 Gy) With Medico-economic Evaluation. Study Summary: Brain metastases (BM) are a common systemic cancer manifestation which incidence increases. Therapeutic options include whole-brain radiotherapy (WBRT), surgery, and stereotactic radiosurgery (SRS). The concept of “oligometastatic” cerebral disease (oligoBM) has emerged and led to consider alternative approaches. The main challenge is to preserve neurological function and independence the longest as possible. Stereotactic radiotherapy (SRT) has emerged as an alternative treatment modality for selected oligoBM patients. It allows to achieve the balance of tumour destruction and normal tissue preservation by precisely and accurately delivering a very high dose of radiation in one (SRS) or a few (HSRT) fractions to a limited, well-defined volume. However, no standard exists for decision-making between SRS and HSRT and this important question is being discussed in the recent literature. HSRT appears particularly interesting, assuming the patient convenience of few fractions, the normal tissue sparing achieved through focal irradiation, and the improved normal tissue tolerance of high dose radiation through fractionation. Common adverse effects of SRT are rare but can occasionally be serious, notably radionecrosis that may induce neurological deficits in patients. Although SRS is often less well-tolerated, it remains the mainstay of treatment. To investigators knowledge, SRS and HSRT have not been prospectively compared. Sponsor: Centre Francois Baclesse Intervention: Hypofractionated SRT (stereotactic radiotherapy) Start Date: 2022-06-29 Last Updated: 2022-08-10 Number of Patients: 504 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Brain Metastasis
NCTID: NCT03143322
Title: Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases Study Summary: Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis). The concept of “oligometastases” was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies. Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient’s quality of life and autonomy, and their accessibility to potentially curative radiotherapy. The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers). Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy <math display="block">SBRT</math>). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy. In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 3 metastases) in solid tumor patients is able to improve the survival without progression. Sponsor: UNICANCER Intervention: SBRT Start Date: 2018-01-24 Last Updated: 2023-03-24 Number of Patients: 196 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT01289522
Title: Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Study Summary: PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: cetuximab IV Start Date: 2009-09 Last Updated: 2017-05-15 Number of Patients: 54 Recruitment Status: COMPLETED Condition: Squamous Cell Head and Neck Carcinoma
NCTID: NCT02689622
Title: PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes. Study Summary: No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value. The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use. To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients’care and prognosis according to the use or not by the doctors of the new scores. Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics. Sponsor: University Hospital, Toulouse Intervention: research of disease-related factors Start Date: 2016-04-20 Last Updated: 2020-07-30 Number of Patients: 157 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT04980222
Title: A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma Study Summary: This Phase II, open-label, multicenter study will evaluate the safety, efficacy, and pharmacokinetics of glofitamab in combination with rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in individuals with circulating tumor DNA (ctDNA) high-risk diffuse large B-cell lymphoma (DLBCL), as the first line of treatment. Sponsor: Hoffmann-La Roche Intervention: Glofitamab Start Date: 2022-03-22 Last Updated: 2023-11-07 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Lymphoma
NCTID: NCT00820547
Title: Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients Study Summary: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer. Sponsor: UNICANCER Intervention: bevacizumab Start Date: 2009-01 Last Updated: 2019-10-22 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03745950
Title: UTOLA: UTerin OLAparib Study Summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer Sponsor: ARCAGY/ GINECO GROUP Intervention: Olaparib Oral Capsule Start Date: 2019-02-01 Last Updated: 2023-11-07 Number of Patients: 147 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Endometrial Carcinoma
NCTID: NCT00427375
Title: Local Excision in Downstaged Rectal Cancer Study Summary: Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy. Good responders (residual tumour =< 2 cm) are randomised in local vs rectal excision, 6-8 weeks after treatment. The composite end point evaluates the rate of patients with death, recurrence, major morbidity or severe after effects at two years. Sponsor: University Hospital, Bordeaux Intervention: local rectal excision Start Date: 2007-03-05 Last Updated: 2018-03-14 Number of Patients: 148 Recruitment Status: COMPLETED Condition: Rectal Neoplasms
NCTID: NCT02414568
Title: Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin Study Summary: This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study. Sponsor: The Lymphoma Academic Research Organisation Intervention: Bendamustine Start Date: 2015-07-17 Last Updated: 2021-02-21 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Classical Hodgkin Lymphoma
NCTID: NCT04366154
Title: Impact of the COVID-19 Infectious Epidemic on the Management of Oncology and Onco-hematology Patients and on the Psychological Consequences for Patients and Caregivers Study Summary: This original study will assess the impact of the coronavirus health crisis on the management of patients undergoing medical treatment for cancer, in particularly on the modification of the hospital organization. It will also provide a record of the progress of patients who will have been treated during the epidemic period and infected by the virus. We will also assess the psychological impact of the pandemic in patients but also in caregivers Sponsor: Centre Francois Baclesse Intervention: Questionnaire Start Date: 2020-04-15 Last Updated: 2020-12-14 Number of Patients: 809 Recruitment Status: UNKNOWN Condition: COVID-19
NCTID: NCT00529503
Title: A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL Study Summary: This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40. Sponsor: Seagen Inc. Intervention: SGN-40 Start Date: 2007-09 Last Updated: 2015-02-25 Number of Patients: 151 Recruitment Status: TERMINATED Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT01562990
Title: Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse Study Summary: The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant. Sponsor: The Lymphoma Academic Research Organisation Intervention: Rituximab, CMC544, Gemcitabine and Oxaliplatine Start Date: 2012-12 Last Updated: 2016-05-23 Number of Patients: 11 Recruitment Status: COMPLETED Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT02257567
Title: A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma Study Summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL. Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2014-10-15 Last Updated: 2022-11-14 Number of Patients: 331 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT03723967
Title: FRAIL-IMMUNE (GORTEC 2018-03) - Combination of Durvalumab With Carboplatin/Paclitaxel Study Summary: The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy. Sponsor: Centre Leon Berard Intervention: Durvalumab with Carboplatin/Paclitaxel Start Date: 2019-05-16 Last Updated: 2022-10-04 Number of Patients: 102 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT03155997
Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Study Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Sponsor: Eli Lilly and Company Intervention: Abemaciclib Start Date: 2017-07-12 Last Updated: 2023-07-14 Number of Patients: 5637 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00002459
Title: Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: radiation therapy Start Date: 1988-04 Last Updated: 2012-09-24 Number of Patients: 224 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT04790903
Title: A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants. Sponsor: Hoffmann-La Roche Intervention: Venetoclax Start Date: 2021-07-02 Last Updated: 2023-09-06 Number of Patients: 50 Recruitment Status: RECRUITING Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT00285103
Title: SPC2996 in Chronic Lymphocytic Leukaemia Study Summary: The purpose of this study is to determine whether SPC2996 is effective and safe in the treatment of Chronic Lymphocytic Leukaemia (CLL) Sponsor: Santaris Pharma A/S Intervention: SPC2996 Start Date: 2005-06 Last Updated: 2011-02-02 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00424203
Title: Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery. Sponsor: UNICANCER Intervention: AC regimen Start Date: 2006-01 Last Updated: 2013-09-04 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT06022003
Title: Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia Study Summary: Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group. Until now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment. In phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg/day before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R/R patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials. The aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia Sponsor: French Innovative Leukemia Organisation Intervention: AzaCITIDine Oral Tablet Start Date: 2023-09-30 Last Updated: 2023-09-06 Number of Patients: 33 Recruitment Status: NOT_YET_RECRUITING Condition: AML, Adult
NCTID: NCT00804856
Title: Phase I/IIa Trial to Investigate BI 6727 (Volasertib) as Monotherapy or in Combination With Cytarabine in Acute Myeloid Leukaemia Study Summary: The trial will be performed in two parts, a phase I part and a phase IIa part. In the phase I part of the trial, BI 6727 will be investigated as monotherapy and in combination with low dose cytarabine (LD-Ara-C) in patients with relapsed/refractory AML that are not eligible for intensive treatment. The dose of BI 6727 will be escalated to determine the maximum tolerated dose (MTD) of BI 6727 monotherapy and BI 6727 in combination with LD-Ara-C in AML patients. In the phase IIa part, the combination of BI 6727 at MTD with LD-Ara-C and LD-Ara-C monotherapy will be investigated to explore the efficacy of the combination schedule in comparison to LD-Ara-C monotherapy in previously untreated AML patients that are not eligible for intensive treatment. Sponsor: Boehringer Ingelheim Intervention: Volasertib Start Date: 2008-11-27 Last Updated: 2023-10-03 Number of Patients: 180 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT00103168
Title: Imatinib Mesylate or Observation Only in Treating Patients Who Have Undergone Surgery for Localized Gastrointestinal Stromal Tumor Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after surgery may kill any remaining tumor cells. It is not yet known whether imatinib mesylate is more effective than observation only in treating gastrointestinal stromal tumor. PURPOSE: This randomized phase III trial is studying imatinib mesylate to see how well it works compared to observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: imatinib mesylate Start Date: 2004-12 Last Updated: 2018-07-09 Number of Patients: 908 Recruitment Status: COMPLETED Condition: Gastrointestinal Stromal Tumor
NCTID: NCT00901615
Title: Lenalidomide and R-CHOP in B-cell Lymphoma Study Summary: The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone). Sponsor: Lymphoma Study Association Intervention: Lenalidomide and R-CHOP Start Date: 2009-01-06 Last Updated: 2018-08-23 Number of Patients: 108 Recruitment Status: COMPLETED Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT04747054
Title: Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers Study Summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers Sponsor: UNICANCER Intervention: Pembrolizumab Start Date: 2021-12-01 Last Updated: 2023-10-13 Number of Patients: 148 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT00275054
Title: Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia Study Summary: RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia. Sponsor: German CLL Study Group Intervention: Fludarabine Start Date: 2005-10 Last Updated: 2019-05-23 Number of Patients: 825 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04181203
Title: Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy Study Summary: This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients. Sponsor: UNICANCER Intervention: Apalutamide Start Date: 2020-01-09 Last Updated: 2022-10-31 Number of Patients: 490 Recruitment Status: RECRUITING Condition: Prostate Cancer
NCTID: NCT02871167
Title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation Study Summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area. Sponsor: Centre Oscar Lambret Intervention: Controlled ovarian hyperstimulation (COH) Start Date: 2016-12 Last Updated: 2023-02-14 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01905943
Title: A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia Study Summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator’s discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years. Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2013-11-04 Last Updated: 2019-10-28 Number of Patients: 979 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04827719
Title: BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS Study Summary: To assess the efficacy, and safety of BST-236 in patients unfit for intensive chemotherapy with AML or HR MDS that failed or relapsed following first line therapy Sponsor: Groupe Francophone des Myelodysplasies Intervention: BST-236 Start Date: 2021-05-01 Last Updated: 2023-01-04 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT01564056
Title: Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment Study Summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test. Sponsor: UNICANCER Intervention: HORMONOTHERAPY Start Date: 2012-04-12 Last Updated: 2023-04-06 Number of Patients: 1989 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT00002903
Title: Docetaxel in Treating Patients With Recurrent or Refractory Germ Cell Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with recurrent or refractory germ cell cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel Start Date: 1995-07 Last Updated: 2012-07-02 Number of Patients: 25 Recruitment Status: COMPLETED Condition: Extragonadal Germ Cell Tumor
NCTID: NCT03644186
Title: To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) Study Summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade. Sponsor: ETOP IBCSG Partners Foundation Intervention: Paclitaxel Start Date: 2019-04-16 Last Updated: 2023-07-25 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02428686
Title: Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS) Study Summary: Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated. In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1. In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance. Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Epoetin beta (NeoRecormon) Start Date: 2010-06 Last Updated: 2015-04-29 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT00138086
Title: Yttrium-90 Ibritumomab Tiuxetan (Zevalin) With BEAM in Relapsed Low Grade B-Cell Lymphoma Study Summary: The objective of this study is to evaluate the efficacy and the safety of Zevalin-BEAM preparative regimen before autologous stem cell transplantation (ASCT) as measured by the event free survival (EFS). The goal is to obtain a 15% increase of EFS at 2 years. Sponsor: Lymphoma Study Association Intervention: Zevalin plus BEAM Start Date: 2005-03 Last Updated: 2006-09-08 Number of Patients: 75 Recruitment Status: COMPLETED Condition: B-Cell Lymphoma
NCTID: NCT01232556
Title: A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy Study Summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator’s choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival. Sponsor: Pfizer Intervention: Inotuzumab ozogamicin Start Date: 2011-04-04 Last Updated: 2019-01-08 Number of Patients: 338 Recruitment Status: TERMINATED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT04428151
Title: Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) Study Summary: This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-08-06 Last Updated: 2023-11-24 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04805203
Title: Analysis of the Immune Parameters of COVID-19 Infection in Patients With Multiple Myeloma Study Summary: Among all MM patients included in the cohort at the time of diagnosis of SARS-CoV-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. The following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, B, T, and NK cells analyses by cytometry, including exhaustion analyses. In addition, T cell repertoire sequencing looking for SARS-CoV-2- specific T cells, and serologies, will be evaluated at recovery and 6 months after MM treatment re-initiation. Sponsor: Intergroupe Francophone du Myelome Intervention: blood sample analyses Start Date: 2020-12-16 Last Updated: 2023-10-19 Number of Patients: 139 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT03609047
Title: Adjuvant Palbociclib in Elderly Patients With Breast Cancer Study Summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Palbociclib Start Date: 2019-06-14 Last Updated: 2022-11-17 Number of Patients: 366 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage II
NCTID: NCT05201547
Title: Endometrial Cancer Patientes MMR Deficient Comparing Chimiotherapy vs Dostarlimab in First Line Study Summary: Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer. Sponsor: ARCAGY/ GINECO GROUP Intervention: Carboplatin-Paclitaxel Start Date: 2022-04-15 Last Updated: 2023-07-27 Number of Patients: 260 Recruitment Status: RECRUITING Condition: Endometrial Cancer
NCTID: NCT01889186
Title: A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion Study Summary: This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion. Sponsor: AbbVie Intervention: ABT-199 (Main Cohort) Start Date: 2013-06-27 Last Updated: 2021-12-16 Number of Patients: 158 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00169143
Title: Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma Study Summary: Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI). Sponsor: Lymphoma Study Association Intervention: Rituximab + ACVBP regimen plus Pegfilgrastim Start Date: 2004-05 Last Updated: 2018-08-23 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Untreated CD20-positive Large B-cell Lymphoma
NCTID: NCT05444712
Title: Transplantation After Complete Response In Patients With T-cell Lymphoma Study Summary: Peripheral T-cell lymphoma (PTCL) encompasses a broad range of post-thymic (i.e., mature) sub-entities as defined by the 2017 WHO classification. The most common entities are angioimmunoblastic T-cell lymphoma (AITL) and other Tfh-phenotype PTCL or PTCL not otherwise specified (NOS), each representing approximately 20 to 25% of mature T- and NK/T-cell lymphomas. Compared to their B-cell counterparts, most PTCL confer dismal prognosis. In fact, except for anaplastic lymphoma kinase (ALK)-positive systemic anaplastic large cell lymphoma (sALCL), 10-year overall survival for patients with PTCL barely exceeds 30%. Given the infrequency and the heterogeneity of these malignancies, no real consensus on first-line treatment has been established for most PTCL. The place of autologous stem cell transplantation (ASCT) as a consolidation procedure for patients with PTCL achieving a complete metabolic response after induction is still highly debated. ESMO recommendations and recent guidelines from a committee of the American Society for Blood and Marrow Transplantation currently propose ASCT as first-line therapy for transplant-eligible patients for all patients reaching at least a partial response (PR) after induction. NCCN guidelines (version 2.2017) recommend ASCT or observation in case of metabolic CR but salvage regimen in case of residual disease after induction. Sponsor: Hospices Civils de Lyon Intervention: Chemotherapy + follow up Start Date: 2022-08-01 Last Updated: 2023-09-28 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT01007292
Title: A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin’s Lymphoma Who Have Received Prior Treatment Study Summary: The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin’s Lymphoma. Sponsor: Astellas Pharma Inc Intervention: YM155 Start Date: 2009-11 Last Updated: 2015-10-19 Number of Patients: 43 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT02227251
Title: Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit. Sponsor: Karyopharm Therapeutics Inc Intervention: Selinexor Start Date: 2014-11 Last Updated: 2023-08-07 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03896412
Title: Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma Study Summary: Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment. Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT…), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient. In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up. Sponsor: Centre Henri Becquerel Intervention: Detecton of circulating tumor DNA Start Date: 2019-01-21 Last Updated: 2020-07-30 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT02244125
Title: A Multicenter Open Label Phase II Study of Pomalidomide and Cyclophosphamide and Dexamethasone in Relapse/Refractory Multiple Myeloma Patients Who Were First Treated Within the IFM/DFCI 2009 Trial Study Summary: Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide (Revlimid) and bortezomib (Velcade), and have demonstrated disease progression on the last therapy. Patients with relapsed and refractory multiple myeloma who have received bortezomib, lenalidomide, dexamethasone combination, considered to be the multiple myeloma optimal treatment, can access to pomalidomide under marketing authorization only as from third line of treatment. In France this combination is not authorized for marketing for a first line treatment and only patient randomized in the IFM/DFCI 2009 trial received it. This study concerns patients previously randomized in the IFM/DFCI 2009 trial who have received bortezomib, lenalidomide and Dexamethasone combination in first line, which at progression/relapse time therapeutic opportunities remained limited and who cannot access pomalidomide under marketing authorization. This study is a multicentre, phase 2, open label, study testing the triple combination of pomalidomide and cyclophosphamide and dexamethasone (PCD) in multiple myeloma patients who are refractory or in first progression/relapse after a first line treatment with bortezomib and lenalidomide, an IMiDs (an Immuno Modulatory Drug and a proteasome inhibitor) according to the IFM/DFCI 2009 trial. In the IFM/DFCI trial, patients in arm A received eight cycles of the Velcade-Revlimid-Dexamethasone combination followed by 1 year of lenalidomide maintenance, patients in arm B received 3 cycles of Velcade-Revlimid-Dexamethasone combination plus melphalan 200mg/m2 with an autologous transplantation followed by 2 cycles of Velcade-Revlimid-Dexamethasone combination consolidation and 1 year of lenalidomide maintenance. This study will contain 3 treatment phases: * Study treatment phase: All patients will receive 4 cycles (28 days) of pomalidomide-cyclophosphamide-dexamethasone combination. * Consolidation phase (depends on the initial randomization in the IFM/DFCI 2009 trial): ** For patients previously randomized in IFM/DFCI 2009’s arm A: *** Melphalan 200 mg/m2 followed by Autologous Transplantation *** Three months after, 2 cycles of pomalidomide-cyclophosphamide-dexamethasone combination ** For patients previously randomized in IFM/DFCI 2009’s arm B: *** 5 cycles of pomalidomide-cyclophosphamide-dexamethasone combination * Maintenance phase (identical to all patients) subsequent cycles of pomalidomide and Dexamethasone until progression / relapse or discontinuation for any other reason. For arm B patients, in case relapse occurs at least 12 months after the end of the maintenance IFM/DFCI 2009 trial, they could proceed to a second autologous transplantation and therefore follow the arm A procedure. The decision to proceed to a second transplant will be made by the physician and the patient. In order to have the same amount of patients enrolled in this trial in the initial Arm A and Arm B of the IFM/DFCI 2009 trial, once 50 patients have been included in either arm A or B, subsequent patients will be eligible if they have not been initially treated as the first 50 patients from either arm. The primary endpoint is the response rate (Partial Response (PR) or better) after 4 cycles of the triple combination pomalidomide and cyclophosphamide and dexamethasone (PCD) in the studied population using International Myeloma Working Group (IMWG) response criteria. Sponsor: Institut Curie Intervention: PCD Start Date: 2014-04-14 Last Updated: 2023-07-05 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01539512
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) Study Summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-04 Last Updated: 2019-05-14 Number of Patients: 220 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00564512
Title: Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP Study Summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia. Sponsor: French Innovative Leukemia Organisation Intervention: Campath Start Date: 2007-11 Last Updated: 2013-07-25 Number of Patients: 178 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT00932412
Title: The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial) Study Summary: This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation. We will compare efficacy and toxicity among the two arms. Sponsor: Hospices Civils de Lyon Intervention: CLARA Start Date: 2009-03 Last Updated: 2016-09-21 Number of Patients: 735 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT00144755
Title: R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma Study Summary: This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 g/dl, compared to classical symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large B-cell lymphoma. Sponsor: Lymphoma Study Association Intervention: Darbepoetin alfa Start Date: 2003-12 Last Updated: 2015-09-02 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT01944943
Title: Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia Study Summary: The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL). Sponsor: The Lymphoma Academic Research Organisation Intervention: Vismodegib Start Date: 2013-02 Last Updated: 2017-03-13 Number of Patients: 31 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT00217607
Title: Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery Study Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery. Sponsor: UNICANCER Intervention: paclitaxel Start Date: 2005-02 Last Updated: 2016-08-30 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT01166737
Title: Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer Study Summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients. Sponsor: AGO Study Group Intervention: Tumor Debulking Surgery (surgery in recurrent ovarian disease) Start Date: 2010-07 Last Updated: 2022-01-25 Number of Patients: 408 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT05241405
Title: Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer Study Summary: This is a multicenter randomized trial in breast cancer patients reporting cancer-related fatigue to evaluate the efficacy and safety of Qiseng® based on extract of American ginseng combined with vitamin C from extract of Camu Camu berries Sponsor: Centre Francois Baclesse Intervention: QISENG Start Date: 2022-09-27 Last Updated: 2023-11-13 Number of Patients: 354 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT00003652
Title: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer. Sponsor: UNICANCER Intervention: cisplatin Start Date: 1999-01-04 Last Updated: 2021-02-17 Number of Patients: 350 Recruitment Status: COMPLETED Condition: Anal Cancer
NCTID: NCT02617745
Title: Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid Study Summary: The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed. Sponsor: Centre Henri Becquerel Intervention: Platelet level determination Start Date: 2015-11-30 Last Updated: 2023-05-03 Number of Patients: 244 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Glioblastoma
NCTID: NCT03170882
Title: A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma Study Summary: The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance. * Ixazomib capsules, given with dexamethasone tablets * Pomalidomide capsules, given with dexamethasone tablets All participants will take their study medicine on specific days during a 28-day cycle. The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home. After treatment, participants will visit the clinic every 12 weeks for a check-up. If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Ixazomib Start Date: 2017-08-01 Last Updated: 2022-12-20 Number of Patients: 122 Recruitment Status: COMPLETED Condition: Relapsed and/or Refractory Multiple Myeloma
NCTID: NCT04199104
Title: A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) Study Summary: This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS). Sponsor: Merck Sharp & Dohme LLC Intervention: Lenvatinib Start Date: 2020-02-05 Last Updated: 2023-11-02 Number of Patients: 511 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT06036706
Title: Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma: Study Summary: For the purpose of this research, investigator will constitute several cohorts of patients, treated either by intensity-modulated radiotherapy, stereotactic radiotherapy or proton-therapy. This will allow better understanding the cognitive and anatomical damages caused by new radiotherapy techniques and better understanding how ionising radiation (X-rays or protons) acts in the long term on brain tissue. Longitudinal follow-up will be multimodal, based on yearly multi-parametric brain MRI to assess morphological changes, in relation with dosimetric data as well as neuropsychological performances, health-related quality of life, anxiety and depression disorders, memory tasks, and socio-professional reintegration. This will notably make it possible to evaluate the relationship between dosimetric data, age at the time of treatment, region of the brain irradiated, type of radiation used, dose per fraction, neurocognitive and neuro-anatomical consequences. A Normal Tissue Control Probability (NTCP) model will be also developed. Overall, the results of this study should contribute to the improvement of treatment techniques, in particular by preserving as much as possible the significant cerebral zones (hippocampi, frontal lobe, sub-ventricular zones, etc.), and to the management of patients by proposing appropriate support measures. In the proton-therapy cohort, evaluations will make it possible to establish more precisely the place that this new irradiation strategy should occupy in the management of low grade meningioma. Importantly, investigator have planned to constitute a last cohort, with subjects free of any neurological disease, to make it easier the interpretation of cognitive performances over time among patients in the three brain radiation cohorts. Sponsor: Centre Francois Baclesse Intervention: Normo-fractionated intensity-modulated brain irradiation with or without stereotactic positioning Start Date: 2023-09-13 Last Updated: 2023-09-14 Number of Patients: 108 Recruitment Status: RECRUITING Condition: Meningioma
NCTID: NCT00655668
Title: A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin’s Lymphoma Study Summary: This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase. Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable adverse events develop. All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase. Objectives: Primary: • To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell Non-Hodgkin’s Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. Secondary: • To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2008-03-01 Last Updated: 2019-11-25 Number of Patients: 54 Recruitment Status: TERMINATED Condition: T-cell Non-Hodgkin’s Lymphoma
NCTID: NCT00483782
Title: Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Sponsor: Medical Research Council Intervention: bevacizumab Start Date: 2006-04 Last Updated: 2013-08-12 Number of Patients: 1520 Recruitment Status: COMPLETED Condition: Fallopian Tube Cancer
NCTID: NCT00003682
Title: Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to make cancer cells stop dividing so they stop growing or die. Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy. Sponsor: UNICANCER Intervention: doxorubicin hydrochloride Start Date: 1998-10 Last Updated: 2016-06-23 Number of Patients: 160 Recruitment Status: TERMINATED Condition: Prostate Cancer
NCTID: NCT05782127
Title: Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes Study Summary: This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Onureg + Venetoclax Start Date: 2023-11 Last Updated: 2023-10-26 Number of Patients: 36 Recruitment Status: NOT_YET_RECRUITING Condition: Untreated Myelodysplastic Syndrome
NCTID: NCT05542706
Title: Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer Study Summary: Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided. This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care). The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients. Sponsor: Centre Henri Becquerel Intervention: Accompanying caregivers by paramedical team Start Date: 2022-10-31 Last Updated: 2022-12-23 Number of Patients: 76 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT00003627
Title: Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed. Sponsor: UNICANCER Intervention: cisplatin Start Date: 1998-10 Last Updated: 2021-02-21 Number of Patients: 160 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT00136552
Title: Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden Study Summary: The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma. Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2000-05 Last Updated: 2007-07-03 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01810705
Title: GRASPA Treatment for Patients With Acute Myeloblastic Leukemia Study Summary: The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy. Sponsor: ERYtech Pharma Intervention: GRASPA Start Date: 2013-02 Last Updated: 2022-02-21 Number of Patients: 123 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT00006026
Title: Nitrocamptothecin in Treating Patients With Metastatic Cancer of the Urinary Tract Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have metastatic cancer of the urinary tract. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rubitecan Start Date: 2000-05 Last Updated: 2012-09-24 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT00848926
Title: A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma Study Summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2009-02 Last Updated: 2017-03-13 Number of Patients: 102 Recruitment Status: COMPLETED Condition: Disease, Hodgkin
NCTID: NCT05696626
Title: Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Study Summary: The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. Sponsor: Sermonix Pharmaceuticals Inc. Intervention: Lasofoxifene in combination with abemaciclib Start Date: 2023-10-31 Last Updated: 2023-11-14 Number of Patients: 400 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: NCT01280526
Title: A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas Study Summary: This study is an open label, multicenter study with two phases: * A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma. * An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma. Sponsor: The Lymphoma Academic Research Organisation Intervention: Romidepsin and CHOP Start Date: 2011-01 Last Updated: 2014-05-22 Number of Patients: 37 Recruitment Status: COMPLETED Condition: Peripheral T Cell Lymphoma
NCTID: NCT03766763
Title: Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A Study Summary: Open label, single arm, multicenter phase II trial. Sponsor: French Innovative Leukemia Organisation Intervention: Venetoclax Start Date: 2019-05-22 Last Updated: 2022-07-27 Number of Patients: 82 Recruitment Status: RECRUITING Condition: Chronic Lymphoid Leukemia
NCTID: NCT03123393
Title: TAK-659 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL. Sponsor: Calithera Biosciences, Inc Intervention: TAK-659 Start Date: 2017-10-10 Last Updated: 2023-02-08 Number of Patients: 49 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT05617963
Title: Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax Study Summary: This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant thoracic CRT and cisplatin-etoposide regimen or a sequential CRT and carboplatin. Patients showing a disease control (defined as stable disease <math display="block">SD</math>, partial response <math display="block">PR</math>, or complete response <math display="block">CR</math> according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be randomized to receive durvalumab every 4 weeks (experimental arm A) or surveillance (control arm B) as per standard of care. Thus, DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT. Sponsor: UNICANCER Intervention: Durvalumab Start Date: 2023-03-24 Last Updated: 2023-03-28 Number of Patients: 550 Recruitment Status: RECRUITING Condition: Small Cell Lung Carcinoma
NCTID: NCT03838263
Title: Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer Study Summary: The aim of this research is to study the feasibility of neoadjuvant treatment before chemoradiation in “high risk” HPV-driven Oropharynx cancer Sponsor: UNICANCER Intervention: Nivolumab Start Date: 2019-07-25 Last Updated: 2023-05-11 Number of Patients: 62 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Oropharynx Cancer
NCTID: NCT03498716
Title: A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer Study Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator’s choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator’s choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer) Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2018-08-02 Last Updated: 2023-09-15 Number of Patients: 2203 Recruitment Status: COMPLETED Condition: Triple Negative Breast Cancer
NCTID: NCT01976182
Title: Prospective, Multicentric, Phase II Randomized Controlled Trial on Two Parallel Groups Comparing the Efficacy of Two Immunosuppressive Drugs (Methotrexate, Cyclophosphamide) in Large Granular Lymphocytes Leukemia Study Summary: LGL leukemia represents a rare subtype of chronic T or NK lymphoproliferative disorders. It is an indolent disease, the main hematological or autoimmune complications lead to a treatment in more than 60% of patients. Investigators set up at the University Hospital of Rennes, a database of more than 300 patients with LGL leukemia from major French services that support this disease, and published in 2010 the largest series of patients in the world (n = 229). However, the limited heterogeneity and retrospective data collected, as all previously released, makes it difficult the proposal of consensual treatment options. If first and second line treatments are based on the use of immunosuppression with methotrexate, cyclophosphamide, or cyclosporin A, no molecule has proven superiority over others. Methotrexate and cyclophosphamide are mainly used in the first line. Invetigators just have in the literature data on about 100 patients treated with either of these drugs. Combining the results of our series with those in the literature, invetigators estimate the respective overall response rate (RG) and complete response rate (CR) in 55% and 30% for methotrexate, and 60% and 50% for cyclophosphamide. Thus, there are four objective in this study : # to compare the respective efficacies of methotrexate and cyclophosphamide when administered as first-line therapies in patients suffering from T
K LGL leukemia with severe neutropenia or neutropenia associated with infections, and/or anemia requiring transfusions, and/or auto-immune associated disease # to evaluate the percentage of patients refractory to methotrexate or cyclophosphamide for which a second line treatment is efficacious # to explore, in case of non-response to the first-line therapy, the efficacy of ciclosporine A, the comparison being performed with the treatment which was not administered in the first-line therapy # to evaluate the response rate according to the phenotypic subtype of LGL leukemia.
Sponsor: Rennes University Hospital Intervention: Methotrexate Start Date: 2013-11-26 Last Updated: 2023-09-14 Number of Patients: 166 Recruitment Status: RECRUITING Condition: Large Granular Lymphocytes Leukemia
NCTID: NCT05006716
Title: A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Study Summary: Study consists of two main parts to explore BGB-16673 recommended dosing, a Part 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a part 2 (dose expansion cohorts) Sponsor: BeiGene Intervention: BGB-16673 Start Date: 2021-09-13 Last Updated: 2023-11-13 Number of Patients: 291 Recruitment Status: RECRUITING Condition: B-cell Malignancy
NCTID: NCT04974216
Title: Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older Study Summary: This study evaluate the efficacy of Tafasitamab and Lenalinomide associated to Rituximab in elderly patients with frontline Diffuse Large B-Cell Lymphoma as assessed by the Overall Response Rate (ORR) after 3 cycles of treatment according to Lugano Response Criteria. Sponsor: The Lymphoma Academic Research Organisation Intervention: Tafasitamab Start Date: 2021-12-20 Last Updated: 2023-03-17 Number of Patients: 71 Recruitment Status: RECRUITING Condition: DLBCL
NCTID: NCT05132582
Title: A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer. Sponsor: Seagen Inc. Intervention: Tucatinib Start Date: 2022-03-07 Last Updated: 2023-11-21 Number of Patients: 650 Recruitment Status: RECRUITING Condition: HER2 Positive Breast Cancer
NCTID: NCT03276468
Title: Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas Study Summary: This study is a multicenter phase II trial which primary objective is to assess the anti-lymphoma activity of atezolizumab associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts: * relapsed/refractory follicular lymphoma (FL) patients * relapsed/refractory aggressive (DLBCL) lymphoma patients * relapsed/refractory other indolent (iNHL) lymphoma patients (MZL and MALT) Sponsor: The Lymphoma Academic Research Organisation Intervention: Atezolizumab Start Date: 2018-02-12 Last Updated: 2023-01-10 Number of Patients: 136 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT03332017
Title: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma Study Summary: The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma. Sponsor: BeiGene Intervention: Zanubrutinib Start Date: 2017-11-15 Last Updated: 2023-11-13 Number of Patients: 217 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
NCTID: NCT04290663
Title: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Study Summary: This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy Sponsor: Centre Francois Baclesse Intervention: Systematic RAI-treatment Start Date: 2020-03-02 Last Updated: 2023-09-07 Number of Patients: 476 Recruitment Status: RECRUITING Condition: Thyroid Cancer
NCTID: NCT04224493
Title: Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma Study Summary: The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as ‘relapsed’ when the disease has come back after treatment and ‘refractory’ when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment. Sponsor: Epizyme, Inc. Intervention: Tazemetostat Start Date: 2019-12-19 Last Updated: 2023-10-26 Number of Patients: 540 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Follicular Lymphoma
NCTID: NCT03951493
Title: Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases Study Summary: Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease. Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases. Sponsor: Institut Cancerologie de l’Ouest Intervention: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions Start Date: 2020-06-23 Last Updated: 2022-04-28 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Vertebral Metastasis
NCTID: NCT02317393
Title: Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy Study Summary: The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy. The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients. Sponsor: Centre Francois Baclesse Intervention: K5-RGD PET Start Date: 2014-12 Last Updated: 2020-07-09 Number of Patients: 16 Recruitment Status: COMPLETED Condition: Non-seminomatous Germ Cell Tumors
NCTID: NCT05371093
Title: Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma Study Summary: The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Sponsor: Kite, A Gilead Company Intervention: Axicabtagene Ciloleucel Start Date: 2022-09-12 Last Updated: 2023-09-08 Number of Patients: 230 Recruitment Status: RECRUITING Condition: Relapsed/Refractory Follicular Lymphoma
NCTID: NCT01290549
Title: A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma Study Summary: This is a Phase I, multicenter, open-label, dose-escalation study of polatuzumab vedotin administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory hematologic malignancies. In Phase Ib, participants will receive polatuzumab vedotin in combination with rituximab. Sponsor: Genentech, Inc. Intervention: Polatuzumab Vedotin Start Date: 2011-03-22 Last Updated: 2017-06-16 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Non-Hodgkins Lymphoma
NCTID: NCT02008006
Title: BENdamustine at Elevated Dose for Relapsed Follicular Lymphoma in Intensification Therapy and Transplantation (BENEFIT) Study Summary: The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (World Health Organisation (WHO) grade 1, 2, 3a). Sponsor: Centre Leon Berard Intervention: BeEAM Start Date: 2014-07-09 Last Updated: 2019-01-08 Number of Patients: 21 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT03673306
Title: Safety of Pregnancy in BRCA Mutated Breast Cancer Patients Study Summary: The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer. Sponsor: Jules Bordet Institute Intervention: Clinical outcomes Start Date: 2017-01-16 Last Updated: 2018-09-17 Number of Patients: 2200 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT03275506
Title: PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer . Study Summary: There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS. After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda). Sponsor: ARCAGY/ GINECO GROUP Intervention: Pembrolizumab Injectable Product - Chemotherapy - Bevacizumab Start Date: 2018-02-26 Last Updated: 2023-09-06 Number of Patients: 91 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer Stage IV
NCTID: NCT00003852
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have germ cell tumors that have not responded to previous chemotherapy. Sponsor: UNICANCER Intervention: filgrastim Start Date: 1998-03 Last Updated: 2016-06-23 Number of Patients: 45 Recruitment Status: TERMINATED Condition: Childhood Germ Cell Tumor
NCTID: NCT01777152
Title: ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas Study Summary: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2013-01-31 Last Updated: 2021-11-30 Number of Patients: 452 Recruitment Status: COMPLETED Condition: Anaplastic Large-Cell Lymphoma
NCTID: NCT00005826
Title: Nitrocamptothecin in Treating Patients With Glioblastoma Multiforme Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have glioblastoma multiforme. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: rubitecan Start Date: 2000-03 Last Updated: 2012-09-24 Number of Patients: 17 Recruitment Status: COMPLETED Condition: Brain and Central Nervous System Tumors
NCTID: NCT01877005
Title: A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin’s Lymphoma Study Summary: Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin’s lymphoma for whom no curative option is available. Sponsor: The Lymphoma Academic Research Organisation Intervention: Ruxolitinib Start Date: 2013-07-04 Last Updated: 2018-08-22 Number of Patients: 33 Recruitment Status: COMPLETED Condition: Hodgkin’s Lymphoma
NCTID: NCT02339805
Title: Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS Study Summary: This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment Sponsor: Centre Henri Becquerel Intervention: next generation sequencing Start Date: 2014-11-01 Last Updated: 2017-07-07 Number of Patients: 30 Recruitment Status: COMPLETED Condition: Non Hodgkin Lymphoma
NCTID: NCT05655663
Title: Evaluation of Vascular Toxicity of Immune Checkpoint Inhibitors in Patients Head and Neck or Lung Cancer Study Summary: Since the introduction of immune checkpoint ihibitors (ICIs) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. Currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining ICIs with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or RNA injected to trigger or increase a specific immune response against the tumor. Other approaches exist, such as oncology-specific “basket” studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. To date, ICIs are part of standard management in the US for patients with several diseases: advanced melanoma, NSCLC, Merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory Hodgkin’s lymphoma, hepatocellular carcinoma, gastric cancer. In addition, trials are underway to investigate the benefit of ICIs in other locations. Thus, taking into account the growing importance of ICIs in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary. Sponsor: Centre Henri Becquerel Intervention: Vascular investigation Start Date: 2022-12-20 Last Updated: 2022-12-19 Number of Patients: 30 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT02900963
Title: Nutritional Status Assessment in Head and Neck Cancer Patients Receiving Radiotherapy or Chemo-radiotherapy Study Summary: Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy. Sponsor: Centre Henri Becquerel Intervention: weekly assessment of patient’s weight Start Date: 2014-04 Last Updated: 2020-07-30 Number of Patients: 280 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT00002904
Title: Ecteinascidin 743 in Treating Adults With Advanced Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating adults with advanced solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: trabectedin Start Date: 1996-02 Last Updated: 2012-07-02 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT04182204
Title: A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT). Sponsor: Hoffmann-La Roche Intervention: Polatuzumab Vedotin Start Date: 2020-02-07 Last Updated: 2023-11-18 Number of Patients: 267 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT04675827
Title: De-escalation Adjuvant Chemo in HER2+/ER-
ode-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade
Study Summary: DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4 cycles) combined with subcutaneous (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200 mg pertuzumab and 600 mg trastuzumab, followed by 600 mg pertuzumab and 600 mg trastuzumab) every 3 weeks for 4 cycles. Surgery will be performed according to local guidelines in all subjects after neoadjuvant treatment. After surgery, subjects who achieve a pCR (defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for additional 14 cycles. Subjects with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In subjects whose residual invasive disease is classified per RCB score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator’s discretion, before the 14 cycles of T-DM1. If histopathological analysis finds that the surgical specimen from a subject with residual disease is ER-positive and/or PR-positive, adjuvant endocrine therapy may be administered concomitantly with study treatment, at the investigator’s discretion and according to local guidelines. Adjuvant radiotherapy will be mandatory after breast-conserving surgery, whereas it will be performed according to local guidelines after mastectomy, and it will be administered concomitantly with pertuzumab and trastuzumab FDC SC in subjects who achieve a pCR, and concomitantly with T-DM1 in subjects with residual invasive disease (after anthracycline-based chemotherapy in subjects assigned to receive this treatment). Sponsor: Jules Bordet Institute Intervention: Pertuzumab and tratuzumab fixed dose combination Start Date: 2022-01-17 Last Updated: 2023-09-05 Number of Patients: 1065 Recruitment Status: SUSPENDED Condition: HER2-positive Breast Cancer
NCTID: NCT01436617
Title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab Study Summary: The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions. Sponsor: Centre Francois Baclesse Intervention: blood sample Start Date: 2010-01 Last Updated: 2013-03-08 Number of Patients: 303 Recruitment Status: COMPLETED Condition: Colon Cancer
NCTID: NCT02039726
Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2014-05 Last Updated: 2021-02-24 Number of Patients: 367 Recruitment Status: COMPLETED Condition: AML
NCTID: NCT00967863
Title: Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18) Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy. Sponsor: UNICANCER Intervention: 3-dimensional conformal radiation therapy Start Date: 2008-10 Last Updated: 2022-10-25 Number of Patients: 500 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT03318263
Title: CIrCuLAting Dna ESr1 Gene Mutations Analysis Study Summary: The estrogen-dependent nature of breast cancer was first reported in 1896 with the publication of George Beatson’s observations on the regression of breast cancer following oophorectomy. Endocrine therapy, targeting ER either directly by selective estrogen receptor modulators (SERMs) and pure antagonists or indirectly by aromatase inhibitors (AIs) that block estrogen production, remains the mainstay of treatment of hormone-sensitive breast cancer in the adjuvant and metastatic settings. Intrinsic (de novo) and acquired endocrine resistance constitutes an important clinical challenge in the treatment of breast cancer and multiple mechanisms are suspected to underlie the emergence of endocrine resistance. The role of the estrogen receptor (ER), encoded by the ESR1 gene, in normal mammary gland development and the progression of breast cancer is well established. ESR1 mutations, occurring in 10 to 30% of ER-positive metastatic breast cancer resistant to AIs, lead to ligand-independent activation of the ER. For patients treated with AIs, monitoring of circulating tumour DNA (ctDNA) for ESR1, PIK3CA and AKT1 mutations could permit early detection of resistance to AIs as recently reported during 2016 American Society of Clinical Oncology (ASCO) meeting. Sponsor: Institut de Cancérologie de Lorraine Intervention: next-generation sequencing (NGS) Start Date: 2017-12-07 Last Updated: 2023-08-04 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04965493
Title: A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-09-20 Last Updated: 2023-10-12 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03842982
Title: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Ovarian Cancer (CHIPPI) Study Summary: This is a phase III, multicenter, interventional and randomized study which evaluates the use of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) coupled with either Primary Debulking Surgery (PDS) or Interval Debulking Surgery (IDS), in patients with ovarian cancer. This study aims to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC combined with standard care (PDS or IDS) or standard care alone. Sponsor: Centre Oscar Lambret Intervention: HIPEC Start Date: 2019-04-01 Last Updated: 2022-12-07 Number of Patients: 362 Recruitment Status: RECRUITING Condition: Ovary Neoplasms
NCTID: NCT04659382
Title: Study to Evaluate Efficacy and Safety of Selective Internal Radiation Therapy Plus Xelox, Bevacizumab and Atezolizumab (Immune Chekpoint Inhibitor) in Patients With Liver-dominant Metastatic Colorectal Cancer Study Summary: The main objective of the SIRTCI study is to evaluate the safety and efficacy of the combination chemotherapy (XELOX: Capecitabine plus oxaliplatin), anti-angiogenic (Bevacizumab), SIRT (TheraSphere®) and ICI (Atezolizumab) in patients with CRC with predominant liver metastases. SIRTCI is a single-arm, prospective, multi-centre phase II study. The main inclusion criteria are patients with MSS mRCC with predominantly non-operable liver metastases and measurable disease. Patients with extra-hepatic metastases can be included since the objective of the study is to induce local and abscopal effects of radiotherapy combined with ICI by stimulating the anti-tumour immune response to destroy both hepatic and extra-hepatic metastases. Sponsor: Federation Francophone de Cancerologie Digestive Intervention: Atezolizumab Start Date: 2020-10-07 Last Updated: 2023-08-18 Number of Patients: 52 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT04528420
Title: Optimised Early Management of Squamous Cell Carcinoma of the Head and Neck Cancer Study Summary: Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment. In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival. While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level. Sponsor: Centre Henri Becquerel Intervention: optimised management Start Date: 2020-09-01 Last Updated: 2020-08-27 Number of Patients: 138 Recruitment Status: NOT_YET_RECRUITING Condition: Squamous Cell Carcinoma of Head and Neck
NCTID: NCT04954820
Title: Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET Study Summary: In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit. Sponsor: Institut du Cancer de Montpellier - Val d’Aurelle Intervention: Lutathera Start Date: 2021-10-18 Last Updated: 2023-06-07 Number of Patients: 146 Recruitment Status: RECRUITING Condition: Neuroendocrine Tumors
NCTID: NCT05675982
Title: Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells Study Summary: The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis. Sponsor: Centre Henri Becquerel Intervention: CAR-T cells monitoring Start Date: 2023-01-02 Last Updated: 2023-01-09 Number of Patients: 40 Recruitment Status: NOT_YET_RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT02055820
Title: A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin’s Lymphoma (NHL) and DLBCL Study Summary: This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin’s Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL. Sponsor: Hoffmann-La Roche Intervention: Venetoclax Start Date: 2013-11-17 Last Updated: 2020-06-11 Number of Patients: 267 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT01810393
Title: A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years Study Summary: This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Start Date: 2013-06-11 Last Updated: 2020-09-04 Number of Patients: 114 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02896582
Title: Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance Study Summary: This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance Sponsor: The Lymphoma Academic Research Organisation Intervention: Obinutuzumab Start Date: 2016-10 Last Updated: 2023-01-10 Number of Patients: 86 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT02473120
Title: Study of ESR1 Mutations in Metastatic Breast Cancer Study Summary: The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer. Sponsor: Centre Henri Becquerel Intervention: Determination of ESR1 mutations Start Date: 2015-06 Last Updated: 2020-07-30 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT00140582
Title: Primary Rituximab and Maintenance Study Summary: * Objectives * Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy * Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma. * Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years. Sponsor: Lymphoma Study Association Intervention: Rituximab Start Date: 2004-12 Last Updated: 2017-03-13 Number of Patients: 1217 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT00885508
Title: A Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Del 5q Study Summary: In this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Lenalidomide Start Date: 2009-02 Last Updated: 2015-04-24 Number of Patients: 85 Recruitment Status: UNKNOWN Condition: Myelodysplastic Syndrome
NCTID: NCT00910091
Title: The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer Study Summary: This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer. Sponsor: Ipsen Intervention: BN83495 Start Date: 2009-08 Last Updated: 2019-01-30 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT03503409
Title: IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome Study Summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH1 patients will be treated with AG120 (IDH1 inhibitor) Sponsor: Groupe Francophone des Myelodysplasies Intervention: AG-120 Start Date: 2019-05-14 Last Updated: 2023-01-04 Number of Patients: 68 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT00136591
Title: A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma Study Summary: This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma. Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study. Sponsor: Lymphoma Study Association Intervention: Bortezomib Start Date: 2005-09 Last Updated: 2010-10-26 Number of Patients: 87 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT01196208
Title: A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001 Study Summary: The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001 Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: NA Last Updated: 2020-09-21 Number of Patients: NA Recruitment Status: NO_LONGER_AVAILABLE Condition: Disease, Hodgkin
NCTID: NCT01539291
Title: Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512) Study Summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2012-10-03 Last Updated: 2019-08-20 Number of Patients: 161 Recruitment Status: TERMINATED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00003991
Title: Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia Study Summary: RATIONALE: Interleukin-2 may stimulate a person’s white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission. PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy. Sponsor: Maxim Pharmaceuticals Intervention: aldesleukin Start Date: 1998-07 Last Updated: 2013-11-06 Number of Patients: 360 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT02920008
Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. Sponsor: Astex Pharmaceuticals, Inc. Intervention: guadecitabine Start Date: 2017-03-16 Last Updated: 2023-05-25 Number of Patients: 302 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03151408
Title: An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia Study Summary: This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months. Sponsor: Helsinn Healthcare SA Intervention: Pracinostat Start Date: 2017-06-23 Last Updated: 2022-03-10 Number of Patients: 406 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT00169208
Title: Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin’s Lymphoma Study Summary: This study is a multicentric trial evaluating the efficacy of the RFM regimen in patients aged 18 to 75 years with relapsed/refractory follicular non-Hodgkin’s lymphoma (NHL). Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2001-04 Last Updated: 2019-08-28 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT01493479
Title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma Study Summary: 90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study. Sponsor: The Christie NHS Foundation Trust Intervention: 90Y Ibritumomab tiuxetan Start Date: 2007-06-06 Last Updated: 2019-10-15 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT02292979
Title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma. Study Summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy. Sponsor: The Lymphoma Academic Research Organisation Intervention: Doxorubicin Start Date: 2015-03 Last Updated: 2022-08-19 Number of Patients: 170 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT03580408
Title: Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma Study Summary: This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. : * In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12. * In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12. * In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure. Sponsor: The Lymphoma Academic Research Organisation Intervention: Nivolumab Start Date: 2018-08-31 Last Updated: 2022-08-19 Number of Patients: 64 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT00022191
Title: Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: cisplatin Start Date: 2001-05 Last Updated: 2013-06-12 Number of Patients: 608 Recruitment Status: COMPLETED Condition: Bladder Cancer
NCTID: NCT02208908
Title: Oral Care and Cancer: Assessing the Contribution of Training Healthcare Teams to Support the Oral Status of Patients Hospitalized in Palliative Situation Study Summary: The purpose of this study is to measure the impact of training on the practical assessment and management of the oral status of patients hospitalized in palliative situation. Sponsor: Centre Francois Baclesse Intervention: Evaluation of the oral conditionand proper care Start Date: 2014-04 Last Updated: 2015-08-06 Number of Patients: 280 Recruitment Status: COMPLETED Condition: Management of Oral Care and Cancer in Palliative Situation
NCTID: NCT02912208
Title: Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes Study Summary: Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The only available treatment for severe thrombocytopenia, in the presence of bleeding, is platelet transfusion. Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS. The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia and low- or intermediate-1 IPSS risk (Index Prognostic Score System). Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients become refractory in the long term. The availability of a treatment that induces the increase of platelet count is extremely important, either in terms of quality of life, and in overall survival. Sponsor: Associazione Qol-one Intervention: Eltrombopag/Revolade Start Date: 2011-06-11 Last Updated: 2022-01-28 Number of Patients: 174 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT01994239
Title: Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy Study Summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy. Sponsor: UNICANCER Intervention: Degarelix Start Date: 2012-12 Last Updated: 2022-05-12 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Adenocarcinoma of Prostate
NCTID: NCT03895671
Title: PONAZA : A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS Study Summary: This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis. The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis. Sponsor: Versailles Hospital Intervention: Ponatinib Start Date: 2019-06-19 Last Updated: 2020-08-07 Number of Patients: 40 Recruitment Status: RECRUITING Condition: CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE
NCTID: NCT02323139
Title: A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients Study Summary: This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Azacitidine and LDE255 Start Date: 2015-02-10 Last Updated: 2018-12-06 Number of Patients: 23 Recruitment Status: COMPLETED Condition: MDS
NCTID: NCT01718379
Title: Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality. Study Summary: The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality. Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Lenalidomide Start Date: 2010-07 Last Updated: 2016-11-08 Number of Patients: 132 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT02490891
Title: Study of the Angiogenesis by PET/CT in Patients With Lymphoma Study Summary: The aim of the study is to measure tumoral angiogenesis modifications by RGD-K5 PET/CT before and after 2 cycles of chemotherapy in patients with lymphoma and a large tumoral mass Sponsor: Centre Henri Becquerel Intervention: RGD K5 PET scan Start Date: 2015-11 Last Updated: 2018-07-11 Number of Patients: 25 Recruitment Status: UNKNOWN Condition: Lymphoma
NCTID: NCT00195871
Title: Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma Study Summary: The primary objective of this study is to evaluate the safety and the efficacy of an adult “acute lymphoblastic leukaemia” type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification. Sponsor: Centre Henri Becquerel Intervention: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide Start Date: 2004-02 Last Updated: 2013-11-07 Number of Patients: 155 Recruitment Status: UNKNOWN Condition: Lymphoblastic Lymphoma
NCTID: NCT02005471
Title: A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B). Sponsor: Hoffmann-La Roche Intervention: Bendamustine Start Date: 2014-03-17 Last Updated: 2023-10-17 Number of Patients: 389 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01702571
Title: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Study Summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants. Sponsor: Hoffmann-La Roche Intervention: Trastuzumab Emtansine Start Date: 2012-11-27 Last Updated: 2022-04-04 Number of Patients: 2185 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT05800275
Title: Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease Study Summary: The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy. Sponsor: UNICANCER Intervention: Tucatinib Oral Tablet Start Date: 2023-11 Last Updated: 2023-11-02 Number of Patients: 30 Recruitment Status: NOT_YET_RECRUITING Condition: Leptomeningeal Metastasis
NCTID: NCT04069468
Title: Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC) Study Summary: The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France. Sponsor: Boston Scientific Corporation Intervention: TheraSphere Start Date: 2019-03-13 Last Updated: 2023-11-18 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT05386550
Title: Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) Study Summary: The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2022-10-06 Last Updated: 2023-11-02 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT04934475
Title: MInimal Residual Disease Adapted Strategy Study Summary: IFM 2020-02 will enroll patients eligible for ASCT less than 66 years. All patients will receive induction based on 6 cycles (28-day) of KRD-Isatuximab (Isa-KRD), in order to achieve deep responses and high MRD negativity rates. Patients will be classified at diagnosis according to cytogenetics (standard vs high-risk cytogenetics defined by the LP score including 17p deletion, t(4;14), del(1p32), gain 1q, trisomy 21 and trisomy 5). Sponsor: Intergroupe Francophone du Myelome Intervention: Isatuximab Start Date: 2021-12-08 Last Updated: 2023-02-28 Number of Patients: 716 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT04824950
Title: Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL) Study Summary: The purpose of this study is to compare the predictive value in terms of specificity of circulating tumor DNA (ctDNA) and positron emission computed tomography (PET-CT) after 2 cycles of chemotherapy (C2), on the probability of obtaining a metabolic complete response after 4 cycles of induction chemotherapy (C4) in patients with primary mediastinal large B cell lymphoma (PMBL) receiving standard R-CHOP14 or R-ACVBP. Sponsor: Centre Henri Becquerel Intervention: Circulating tumor DNA monitoring Start Date: 2021-03-22 Last Updated: 2021-04-01 Number of Patients: 87 Recruitment Status: RECRUITING Condition: Primary Mediastinal Large B-cell Lymphoma
NCTID: NCT03946579
Title: Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer Study Summary: The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer Sponsor: Centre Henri Becquerel Intervention: self questionnaires Start Date: 2018-10-16 Last Updated: 2022-12-23 Number of Patients: 14 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02335268
Title: Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia Study Summary: There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim. Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH Intervention: N-Plate / romiplostim Start Date: 2015-05-21 Last Updated: 2023-08-16 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT04010968
Title: Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia Study Summary: The aim of this study is to test the potential benefit of an innovative combination of targeted therapy over the standard the immunochemotherapy (FCR). The interest in this study resides in an MRD driven discontinuation of the novel agents, and a fixed maximum duration of these agents. This design allows a true comparison of the efficacy of IV with the immuno-chemotherapy at 2 years of treatment and later. Finally, other trials propose to include to all risk categories of patients, and we are developing here a stratification preventing the dilution of the results. The intermediate risk patients are the ones for which alternative to chemotherapy is critical, as chemotherapy is likely to alter the clonal evolution of their disease, whereas the low risk patients are already doing well with standard treatment and are likely to benefit from other therapies as well. The high risk patients, id est patients with 17p deletion and or TP 53 mutational status responded very well to new drugs as BTK inhibitors or BLC2 inhibitors. Sponsor: French Innovative Leukemia Organisation Intervention: venetoclax and ibrutinib (I+VEN) Start Date: 2019-09-27 Last Updated: 2022-07-27 Number of Patients: 120 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Intermediate Risk Chronic Lymphocytic Leukemia
NCTID: NCT01466868
Title: Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma Study Summary: The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in patients with relapsed or refractory diffuse large B cell lymphoma. Sponsor: Centre Leon Berard Intervention: MK2206 Start Date: 2011-11 Last Updated: 2014-07-10 Number of Patients: 22 Recruitment Status: TERMINATED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT06006117
Title: Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma Study Summary: This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R/R MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib. The patients will be Randomized as follows: Arm A - Experimental arm: • Mosunetuzumab-Lenalidomide Arm B - Comparator arms ( Investigator Choices): * Rituximab-Lenalidomide * Rituximab-Bendamustine * Rituximab-CHOP Sponsor: The Lymphoma Academic Research Organisation Intervention: Mosunetuzumab + Lenalidomide Start Date: 2023-09-05 Last Updated: 2023-09-28 Number of Patients: 260 Recruitment Status: RECRUITING Condition: Marginal Zone Lymphoma
NCTID: NCT02311959
Title: Therapeutic Nipple Sparing Mastectomy. Study Summary: This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test. The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients could be treated with nipple sparing mastectomy (NSM) with an acceptable low local recurrence rates. 450 patients will be included over a period of 4 years and will be followed for a 5 years period (twice a year). All patients must have a complete preoperative evaluation (bilateral mammography, bilateral breast ultrasonography +/- MRI), and a histopathological diagnostic proof of carcinoma (invasive or in situ, all histopathological types, first treatment or relapse). The study procedure is represented by nipple areola skin-sparing mastectomy followed by immediate breast reconstruction. After surgery, early and late complications, including specific complications (suffering of the nipple-areolar complexe and suffering of the skin flaps), will be evaluate. An esthetic evaluation (by patient and clinician) and a quality of life evaluation will be realized throughout the study. A complementary study, prospective, non-interventional, will be proposed to patients who will benefit from the same surgical technique (NSM) followed by immediate reconstruction, but in the context of preventive surgery (prophylactic surgery for patients mutated or high genetic risk). The aim of this complementary study, which will include a maximum of 60 patients, is to evaluate associated morbidity in prophylactic NSM. Data will be collected over a 3 months period after surgery. Sponsor: Institut Claudius Regaud Intervention: Nipple sparing mastectomy Start Date: 2015-02-09 Last Updated: 2023-08-03 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01567475
Title: The Combination of Rad001 and Rituximab In Patients With Non-hodgkin’s Lymphomas Study Summary: This study is an open label, multicenter study with two phases: * Phase I is a dose escalation study of RAD001 in combination with one injection of Rituximab 375 mg/m² per week during 4 weeks (28 days) in patients CD20 positive non-Hodgkin’s lymphomas to determine the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD). The purpose of the study is to assess the feasibility of the combination based on - rate of dose limiting toxicities (DLT) and PK drug-drug interaction (DDI). * Phase II will define the efficacy and safety profile of RAD001 and Rituximab combination at the RP2D in patients with lymphomas. Patients with lymphomas will be treated at the RP2D established during phase I and evaluated for clinical benefit rate, comprising complete responses (CR + CRu), partial responses (PR) and stable disease (SD), and time to progression using the IWG criteria for treatment response. Induction therapy will follow the same schedule than during the phase I study. Maintenance therapy: Monthly cycles for up to 2 years with: * Daily RAD001 at the same dose than during induction therapy. * Rituximab infusion every other cycle at 375 mg/m2 that correspond to the usual maintenance schedule for Rituximab. Response to therapy will be assessed between day 42 and day 49, then every two months. Sponsor: The Lymphoma Academic Research Organisation Intervention: Everolimus and rituximab Start Date: 2011-12 Last Updated: 2016-03-15 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphomas
NCTID: NCT01671904
Title: A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL) Study Summary: This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V. Sponsor: Genentech, Inc. Intervention: Bendamustine Start Date: 2014-01-13 Last Updated: 2020-10-14 Number of Patients: 84 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00878709
Title: Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer Study Summary: The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab. Sponsor: Puma Biotechnology, Inc. Intervention: neratinib Start Date: 2009-07-09 Last Updated: 2021-06-11 Number of Patients: 2840 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03744390
Title: IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome Study Summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH2 patients will be treated with AG221 (IDH2 inhibitor) Sponsor: Groupe Francophone des Myelodysplasies Intervention: AG-221 Start Date: 2019-04-02 Last Updated: 2023-01-04 Number of Patients: 68 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT00169156
Title: A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma Study Summary: To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL. Sponsor: Lymphoma Study Association Intervention: Rituximab Start Date: 2005-12 Last Updated: 2017-03-13 Number of Patients: 27 Recruitment Status: COMPLETED Condition: Untreated T-cell Angioimmunoblastic Lymphoma
NCTID: NCT02426697
Title: Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy Study Summary: The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations Sponsor: Centre Henri Becquerel Intervention: fentanyl transmucosal Start Date: 2015-05 Last Updated: 2018-07-23 Number of Patients: 120 Recruitment Status: UNKNOWN Condition: Bone Metastasis
NCTID: NCT04809467
Title: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) Study Summary: The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-09-16 Last Updated: 2023-08-08 Number of Patients: 54 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT00169195
Title: Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma Study Summary: The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation. Sponsor: Lymphoma Study Association Intervention: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX) Start Date: 2003-04 Last Updated: 2015-09-02 Number of Patients: 49 Recruitment Status: COMPLETED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT02268695
Title: Platinum-Cetuximab Combined With Docetaxel or With 5FU in Patients With Recurrent/Metastatic HNSCC Study Summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen. Sponsor: Groupe Oncologie Radiotherapie Tete et Cou Intervention: Cisplatin Start Date: 2014-10-10 Last Updated: 2022-08-23 Number of Patients: 541 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT03818061
Title: Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck Study Summary: This proof-of-concept study aims to assess the clinical and biological effects of Atezolizumab combined with Bevacizumab in advanced previously treated squamous-cell carcinoma of the head and neck (HNSCC). Sponsor: Centre Leon Berard Intervention: Atezolizumab Start Date: 2019-03-26 Last Updated: 2023-09-28 Number of Patients: 33 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT00005053
Title: Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with a saline solution may protect kidney cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to compare the effectiveness of glufosfamide with or without hydration in treating patients who have pancreatic cancer that is metastatic or cannot be removed by surgery. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: glufosfamide Start Date: 1999-12 Last Updated: 2012-09-24 Number of Patients: 35 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT00794261
Title: Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Study Summary: The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study. Sponsor: Centre Leon Berard Intervention: Injection of Pegfilgrastim Start Date: 2008-09 Last Updated: 2010-07-08 Number of Patients: 150 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00049595
Title: Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 2002-08 Last Updated: 2023-11-09 Number of Patients: 552 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00056095
Title: Allogeneic Stem Cell Transplant in Treating Patients With Metastatic Kidney Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well allogeneic stem cell transplant works in treating patients with metastatic kidney cancer. Sponsor: UNICANCER Intervention: therapeutic allogeneic lymphocytes Start Date: 2002-11-04 Last Updated: 2021-02-24 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Kidney Cancer
NCTID: NCT00417495
Title: Sentinel Lymph Node Technique in Multifocal Breast Cancer Study Summary: The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer Sponsor: Centre Oscar Lambret Intervention: Sentinel Lymph Node Technique Start Date: 2006-03 Last Updated: 2016-01-06 Number of Patients: 216 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04446962
Title: LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV) Study Summary: This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT). Sponsor: Institut Curie Intervention: Lenalidomide Start Date: 2020-10-30 Last Updated: 2022-12-01 Number of Patients: 128 Recruitment Status: RECRUITING Condition: Lymphoma, Large B-Cell, Diffuse
NCTID: NCT02686346
Title: Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE Study Summary: This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma. Sponsor: The Lymphoma Academic Research Organisation Intervention: Brentuximab Vedotin Start Date: 2016-03 Last Updated: 2021-12-07 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Hodgkin Disease
NCTID: NCT01343173
Title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukaemia in Long Term After Stopping Imatinib Study Summary: Background: Complete molecular remission under imatinib, therapeutic interruption possible for patients in complete remission proved in different trials. Purpose: Stopping imatinib in patients with chronic myeloid leukemia in complete molecular remission during two following years. The objectives of this study are to determine the rate of patients without a molecular relapse and so the rate of molecular relapse, to determine and to seek for clinical and biological CML-related factors predictive for a molecular relapse after imatinib discontinuation. These objectives require to increase the number of study patients to be enrolled for accurate statistical considerations. It will allow to predict which patients have to be proposed for discontinuation without risk of molecular relapse and to select the patients who need to continue or reinforce the treatment to achieve a complete long term eradication of the disease. Sponsor: University Hospital, Bordeaux Intervention: Imatinib stop Start Date: 2011-04-06 Last Updated: 2018-03-13 Number of Patients: 220 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukaemia
NCTID: NCT04391946
Title: Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19 Study Summary: The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 <math display="block">1</math>. Globally, it has been placed in the “pandemic” stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012. Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD. Sponsor: French Innovative Leukemia Organisation Intervention: Data registry Start Date: 2020-03-14 Last Updated: 2023-05-24 Number of Patients: 162 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
NCTID: NCT05934929
Title: Contribution of Residual Tumour DNA Testing on the Surgical Bed Study Summary: The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision. Sponsor: Centre Henri Becquerel Intervention: Circulating tumor DNA detection Start Date: 2023-08-01 Last Updated: 2023-07-07 Number of Patients: 26 Recruitment Status: NOT_YET_RECRUITING Condition: Squamous Cell Carcinoma of the Oral Cavity
NCTID: NCT01397877
Title: GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer Study Summary: This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy. Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2). Disease progression is defined by the RECIST 1.1 criteria Sponsor: ARCAGY/ GINECO GROUP Intervention: BKM120 Start Date: 2011-12 Last Updated: 2023-09-06 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT01736683
Title: Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML) Study Summary: The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML). Sponsor: Merck Sharp & Dohme LLC Intervention: Sotatercept Start Date: 2012-11-28 Last Updated: 2022-10-24 Number of Patients: 74 Recruitment Status: COMPLETED Condition: Anemia
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-21 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02741388
Title: A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP Study Summary: This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation phase will be followed by an exploratory expansion phase in the same population with 12 patients enrolled in each group, who will receive selinexor at the RP2D. The “3+3” design will be applied for dose escalation. The escalation will be performed independently in two distinct groups: * Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles) * Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles) The choice of the conventional immunotherapy regimen which will be administered to each patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator’s decision before patient’s inclusion. Different dose levels for selinexor administration will be examined sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per 3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will continue until the MTD is exceeded or until the highest dose level defined in the study (DL3) is reached. Dose escalation to the next planned dose level will be decided by the DEC based on the number of DLTs observed during the DLT assessment period. The dose escalation phase will be followed by an exploratory expansion phase in the same two groups (Groups A and B), depending on the decision of the Independent Data Monitoring Committee (IDMC) after review of safety data at the end of dose escalation part. Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the investigator’s choice). Sponsor: The Lymphoma Academic Research Organisation Intervention: selinexor Start Date: 2016-10 Last Updated: 2021-12-07 Number of Patients: 39 Recruitment Status: COMPLETED Condition: B-cell Lymphoma
NCTID: NCT00430365
Title: Maintenance Therapy Using Lenalidomide in Myeloma Study Summary: Maintenance treatment of myeloma. Sponsor: University Hospital, Toulouse Intervention: lenalidomide Start Date: 2006-06 Last Updated: 2019-04-26 Number of Patients: 614 Recruitment Status: COMPLETED Condition: Myeloma
NCTID: NCT04595565
Title: Sacituzumab Govitecan in Primary HER2-negative Breast Cancer Study Summary: Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to: * Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles); * Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation. Treatment in either arm will be given for eight cycles. In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents. Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting. Sponsor: German Breast Group Intervention: Capecitabine Start Date: 2020-10-28 Last Updated: 2023-03-02 Number of Patients: 1332 Recruitment Status: RECRUITING Condition: HER2-negative Breast Cancer
NCTID: NCT02416388
Title: Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR Study Summary: This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest. Sponsor: University Hospital, Angers Intervention: Idarubicin Start Date: 2015-01 Last Updated: 2020-10-20 Number of Patients: 3100 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT03975647
Title: A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer Study Summary: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle. Sponsor: Seagen Inc. Intervention: tucatinib Start Date: 2019-10-02 Last Updated: 2023-11-21 Number of Patients: 565 Recruitment Status: RECRUITING Condition: HER2-positive Breast Cancer
NCTID: NCT05254743
Title: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2022-07-22 Last Updated: 2023-10-12 Number of Patients: 650 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01035268
Title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella Study Summary: This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision. It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision. follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse. During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos. Sponsor: Institut Claudius Regaud Intervention: fatty tissue transfer Start Date: 2010-02-08 Last Updated: 2018-08-22 Number of Patients: 196 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT03229200
Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Study Summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Sponsor: Pharmacyclics Switzerland GmbH Intervention: Ibrutinib Start Date: 2017-05-22 Last Updated: 2023-11-24 Number of Patients: 600 Recruitment Status: ENROLLING_BY_INVITATION Condition: Lymphoma, B-Cell
NCTID: NCT01992653
Title: A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin’s Lymphoma Study Summary: This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin’s lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination. Sponsor: Genentech, Inc. Intervention: Cyclophosphamide Start Date: 2013-11-29 Last Updated: 2023-03-14 Number of Patients: 85 Recruitment Status: COMPLETED Condition: Lymphoma, Non Hodgkin
NCTID: NCT00426764
Title: A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma Study Summary: The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy. Sponsor: Celgene Intervention: Romidepsin Start Date: 2007-06-19 Last Updated: 2020-02-11 Number of Patients: 131 Recruitment Status: COMPLETED Condition: Peripheral T-cell Lymphoma
NCTID: NCT01715961
Title: Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma Study Summary: This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma. Sponsor: Centre Henri Becquerel Intervention: anthropometric measurement Start Date: 2012-01 Last Updated: 2016-10-05 Number of Patients: 98 Recruitment Status: COMPLETED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT03930953
Title: A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) Study Summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin’s lymphomas. Sponsor: Celgene Intervention: CC-99282 Start Date: 2019-05-20 Last Updated: 2023-11-01 Number of Patients: 348 Recruitment Status: RECRUITING Condition: Lymphoma, Non-Hodgkin
NCTID: NCT04174053
Title: Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units Study Summary: Connected medicine “2.0” is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc. However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization. Sponsor: Centre Henri Becquerel Intervention: Enteric capsule Start Date: 2019-06-21 Last Updated: 2019-11-22 Number of Patients: 30 Recruitment Status: UNKNOWN Condition: Haematological Malignancy
NCTID: NCT04699461
Title: Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine Versus Idelalisib in Participants With Relapsed or Refractory Follicular Lymphoma Study Summary: This study aims to evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma. Sponsor: ADC Therapeutics S.A. Intervention: Loncastuximab Tesirine Start Date: 2021-11-04 Last Updated: 2023-10-23 Number of Patients: 6 Recruitment Status: TERMINATED Condition: Relapsed Follicular Lymphoma
NCTID: NCT05068973
Title: Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients Study Summary: Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy. At the time of insertion near the tumor, the Luciola’s 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment. Sponsor: Hospital St. Joseph, Marseille, France Intervention: NOVATECH® LUCIOLA™ EB - (Fiducial Marker) Start Date: 2021-11-18 Last Updated: 2023-01-27 Number of Patients: 35 Recruitment Status: RECRUITING Condition: Lung Cancer
NCTID: NCT04790253
Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) Study Summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Prophylactic cranial irradiation Start Date: 2022-10-27 Last Updated: 2023-11-03 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT03793361
Title: Phase II Study of Regorafenib as Maintenance Therapy Study Summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy. Sponsor: Centre Oscar Lambret Intervention: Regorafenib Start Date: 2019-05-15 Last Updated: 2023-06-23 Number of Patients: 126 Recruitment Status: SUSPENDED Condition: Metastatic Soft Tissue Sarcoma
NCTID: NCT02322853
Title: A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors Study Summary: Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor. Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway. LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2). Sponsor: Centre Francois Baclesse Intervention: Tamoxifen Start Date: 2015-01 Last Updated: 2017-05-24 Number of Patients: 8 Recruitment Status: TERMINATED Condition: Postmenopausal
NCTID: NCT00002777
Title: Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen. PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: exemestane Start Date: 1996-05 Last Updated: 2012-07-02 Number of Patients: 342 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02128061
Title: Efficacy of Lenalidomide in Combination With Subcutaneous Rituximab + miniCHOP in DLBCL Patients of 80 y/o or+ Study Summary: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP). Sponsor: The Lymphoma Academic Research Organisation Intervention: Lenalidomide Start Date: 2014-08 Last Updated: 2021-04-13 Number of Patients: 250 Recruitment Status: COMPLETED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT03683277
Title: IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic Study Summary: This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities. Sponsor: Intergroupe Francophone du Myelome Intervention: Ixazomib/Pomalidomide/Dexamethasone Start Date: 2019-11-03 Last Updated: 2023-06-05 Number of Patients: 26 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT00210353
Title: Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma Study Summary: Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone. In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: chlorambucil (drug) Start Date: 2003-01 Last Updated: 2019-06-06 Number of Patients: 454 Recruitment Status: COMPLETED Condition: Lymphoma, Mucosa-Associated Lymphoid Tissue
NCTID: NCT04921553
Title: Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING) Study Summary: This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers. In addition of clinical data from the medical files, a quality of life questionnaire (QLQ-C30) will be complete at inclusion, at each new treatment and then every 6 months. The patients will be followed for a period of at least 2 years after the inclusion. This TRacKING registry is a European collaborative tool to improve the management of patients with actionable fusions, by sharing of data from rare tumor indications. Sponsor: Centre Leon Berard Intervention: Data collection and quality of life questionnaire Start Date: 2021-06-22 Last Updated: 2021-08-02 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Cancer
NCTID: NCT03223961
Title: A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS Study Summary: This is an open-label, randomized, multicenter, phase III study Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks: * Either at diagnosis Or * at the Hb threshold chosen for RBC transfusions (must be < 9g/dl) Sponsor: Groupe Francophone des Myelodysplasies Intervention: EPREX Start Date: 2018-03-26 Last Updated: 2020-12-02 Number of Patients: 124 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT01663753
Title: Diagnostic Performance of 18F-FDG-PET and Diffusion-weighted MRI in the Assessment of Stage IB to IIB2 Cervical Squamous-cell Carcinoma Response to Concomitant Radiochemotherapy and Brachytherapy Study Summary: Rationale: The benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (SCC) treatment. Scarce studies evaluated the interest of 18F-FDG-PET and MRI in the assessment of response to treatment before surgery. A positive predictive value of 75% was found in a small study making 18F-FDG-PET a promising tool to assess tumor response and guide surgical approach. Diffusion-weighted MRI was also described as an early and sensitive indicator in other diseases. Objectives: The main objective of this study is to evaluate the sensitivity of 18F-FDG-PET in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. Secondary objectives focus on 18F-FDG-PET specificity and likehood ratios as well as diffusion-weighted MRI diagnostic performances. Method: We will conduct a prospective cohort study of 148 women with a stage IB to IIB2 cervical SCC recruited over 2.5 years in 24 centers in France. Each patient will undergo a 18F-FDG-PET and a diffusion-weighted MRI before surgery and 8 weeks after completion of the brachytherapy. The total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18F-FDG-PET and diffusion-weighted MRI, and 3 weeks until surgery. Expected results: 18F-FDG-PET and diffusion-weighted MRI could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical SCC treatment. If so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy. Sponsor: Hospices Civils de Lyon Intervention: 18F-FDG-PET Start Date: 2012-03 Last Updated: 2019-01-07 Number of Patients: 146 Recruitment Status: COMPLETED Condition: Cancer of the Uterine Cervix
NCTID: NCT01331629
Title: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer Study Summary: The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue. Sponsor: Centre Francois Baclesse Intervention: ART-THERAPIE Start Date: 2010-07 Last Updated: 2017-03-14 Number of Patients: 322 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01248429
Title: Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases Study Summary: This study describes the elevation of CPK in patient treated for solid tumors by TKI Sponsor: Centre Oscar Lambret Intervention: CPK dosage Start Date: 2010-11 Last Updated: 2012-06-07 Number of Patients: 154 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT05198960
Title: AVAJAK: Apixaban/Rivaroxaban Versus Aspirin for Primary Prevention of Thrombo-embolic Complications in JAK2V617F-positive Myeloproliferative Neoplasms Study Summary: Philadelphia-negative myeloproliferative neoplasms (MPN) are frequent and chronic myeloid malignancies including Polycythemia Vera (PV), essential thrombocythemia (ET), Primary Myelofibrosis (PMF) and Prefibrotic myelofibrosis (PreMF). These MPNs are caused by the acquisition of mutations affecting activation/proliferation pathways in hematopoietic stem cells. The principal mutations are JAK2V617F, calreticulin (CALR exon 9) and MPL W515. ET or MFP/PreMF patients who do not carry one of these three mutations are declared as triple-negative (3NEG) cases even if they are real MPN cases. These diseases are at high risk of thrombo-embolic complications and with high morbidity/mortality. This risk varies from 4 to 30% depending on MPN subtype and mutational status. In terms of therapy, all patients with MPNs should also take daily low-dose aspirin (LDA) as first antithrombotic drug, which is particularly efficient to reduce arterial but not venous events. Despite the association of a cytoreductive drug and LDA, thromboses still occur in 5-8% patients/year. All these situations have been explored in biological or clinical assays. All of them could increase the bleeding risk. We should look at different ways to reduce the thrombotic incidence: Direct Oral Anticoagulants (DOAC)? In the general population, in medical or surgical contexts, DOACs have demonstrated their efficiency to prevent or cure most of the venous or arterial thrombotic events. At the present time, DOAC can be used in cancer populations according to International Society on Thrombosis and Haemostasis (ISTH) recommendations, except in patients with cancer at high bleeding risk (gastro-intestinal or genito-urinary cancers). Unfortunately, in trials evaluating DOAC in cancer patients, most patients have solid rather than hematologic cancers (generally less than 10% of the patients, mostly lymphoma or myeloma). In cancer patients, DOAC are also highly efficient to reduce the incidence of thrombosis (-30 to 60%), but patients are exposed to a higher hemorrhagic risk, especially in digestive cancer patients. In the cancer population, pathophysiology of both thrombotic and hemorrhagic events may be quite different between solid cancers and MPN. If MPN patients are also considered to be cancer patients in many countries, the pathophysiology of thrombosis is quite specific (hyperviscosity, platelet abnormalities, clonality, specific cytokines…) and they are exposed to a lower risk of digestive hemorrhages. It is thus difficult to extend findings from the “general cancer population” to MPN patients. Unfortunately, only scarce, retrospective data regarding the use of DOAC in MPNs are available data. We were the first to publish a “real-life” study about the use, the impact, and the risks in this population. In this local retrospective study, 25 patients with MPN were treated with DOAC for a median time of 2.1 years. We observed only one thrombosis (4%) and three major hemorrhages (12%, after trauma or unprepared surgery). Furthermore, we have compared the benefit/risk balance compared to patients treated with LDA without difference. With the increasing evidences of efficacy and tolerance of DOAC in large cohorts of patients including cancer patients, with their proven efficacy on prevention of both arterial and venous thrombotic events and because of the absence of prospective trial using these drugs in MPN patients, we propose to study their potential benefit as primary thrombotic prevention in MPN. Sponsor: University Hospital, Brest Intervention: Direct Oral Anticoagulants Start Date: 2022-07-13 Last Updated: 2023-10-30 Number of Patients: 1308 Recruitment Status: RECRUITING Condition: Polycythemia Vera
NCTID: NCT01332929
Title: Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis Study Summary: This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and whole brain radiation therapy for the treatment of patients with brain metastasis of solid tumors. If this therapeutic scheme confirms it’s safety profile, the investigators can expect: * first, to allow that all patients can receive bevacizumab for their advanced and/or metastatic cancer if necessary, even in case of brain metastasis. * Secondly, if this trial confirm a synergic effect of the combination of angiogenesis inhibitors and brain radiotherapy for local control of brain metastasis, an improvement of the therapeutic results for these patients which have a poor hope of survival and for which none innovative approach is currently suggested. Moreover, the investigators hope that the analysis of the different data of MRI evaluation - morphological and functional - will allow better definition of radiological evaluation of the therapeutic effect of angiogenesis inhibitors on brain metastasis. Sponsor: Centre Francois Baclesse Intervention: Bevacizumab Start Date: 2010-06 Last Updated: 2013-09-12 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Metastatic Malignant Neoplasm to Brain
NCTID: NCT01191060
Title: Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Study Summary: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months). Sponsor: University Hospital, Toulouse Intervention: Lenalidomide, Bortezomib Start Date: 2010-10 Last Updated: 2019-04-18 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Myeloma
NCTID: NCT00017095
Title: Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient. PURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: filgrastim Start Date: 2001-03 Last Updated: 2013-10-24 Number of Patients: 1856 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04961996
Title: A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Study Summary: This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population. Sponsor: Hoffmann-La Roche Intervention: Giredestrant Start Date: 2021-08-27 Last Updated: 2023-11-18 Number of Patients: 4200 Recruitment Status: RECRUITING Condition: Early Breast Cancer
NCTID: NCT02490696
Title: Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer Study Summary: The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry. Sponsor: Centre Henri Becquerel Intervention: Miso PET scan Start Date: 2015-06-01 Last Updated: 2020-07-30 Number of Patients: 23 Recruitment Status: COMPLETED Condition: Non-small Cell Lung Cancer
NCTID: NCT01305135
Title: Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes Study Summary: Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing. For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS. For the phase II study: Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS Sponsor: Groupe Francophone des Myelodysplasies Intervention: azacitidine and idarubicin Start Date: 2010-12-30 Last Updated: 2017-06-07 Number of Patients: 41 Recruitment Status: COMPLETED Condition: High Grade Myelodysplastic Syndrome Lesions
NCTID: NCT05581121
Title: PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer Study Summary: This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Each patient will be followed up for 5 years. Sponsor: Institut Claudius Regaud Intervention: Standard treatment: Control arm Start Date: 2023-12 Last Updated: 2023-10-30 Number of Patients: 510 Recruitment Status: NOT_YET_RECRUITING Condition: Cervical Carcinoma
NCTID: NCT00055731
Title: Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse Study Summary: RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse. Sponsor: UNICANCER Intervention: bicalutamide Start Date: 2002-11-14 Last Updated: 2023-01-18 Number of Patients: 413 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01865110
Title: R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL Study Summary: This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab). Sponsor: The Lymphoma Academic Research Organisation Intervention: R-CHOP Start Date: 2013-11 Last Updated: 2023-09-26 Number of Patients: 623 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT04963946
Title: STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia Study Summary: The irreversible Bruton’s Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL). However, a growing body of concerns is raising regarding the unlimited administration of targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk of specific adverse events (infections, bleeding events or cardiovascular problems). Second, continuous administration might also increase the risk of clonal evolution and therapeutic resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation of therapy after a fixed period is expected to prevent these events. Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA discontinuation and efficacy of restarting ACA upon symptomatic relapse. Sponsor: French Innovative Leukemia Organisation Intervention: Stop ACA Start Date: 2021-10-18 Last Updated: 2023-05-24 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Untreated Chronic Lymphocytic Leukemia
NCTID: NCT01442662
Title: Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine Study Summary: The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine. Sponsor: UNICANCER Intervention: pazopanib + gemcitabine Start Date: 2011-09 Last Updated: 2020-01-31 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Leiomyosarcoma
NCTID: NCT02757989
Title: Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome Low Risk Study Summary: Comparison of survival in patients with or without a matched donor at 36 months Sponsor: Groupe Francophone des Myelodysplasies Intervention: transplantation Start Date: 2016-05-31 Last Updated: 2023-02-23 Number of Patients: 79 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: MDS
NCTID: NCT01098188
Title: LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia Study Summary: This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen. Sponsor: Laboratoire français de Fractionnement et de Biotechnologies Intervention: LFB-R603 Start Date: 2008-11 Last Updated: 2012-04-30 Number of Patients: 33 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02348489
Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Study Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy. Sponsor: Astex Pharmaceuticals, Inc. Intervention: SGI-110 (guadecitabine) Start Date: 2015-03-19 Last Updated: 2021-01-14 Number of Patients: 815 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: NCT04892173
Title: NBTXR3 With or Without Cetuximab in LA-HNSCC Study Summary: This is a global, open-label, randomized, 2-arm, Investigator’s choice Phase 3 (Pivotal Stage) study to investigate the efficacy/performance and safety of NBTXR3/RT±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with LA-HNSCC. Sponsor: Nanobiotix Intervention: NBTXR3 Start Date: 2022-01-05 Last Updated: 2023-01-03 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Locally Advanced Head and Neck Squamous Cell Carcinoma
NCTID: NCT03467373
Title: A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL Study Summary: This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; <math display="block">G</math>), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts: * Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1 * Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP. Sponsor: Hoffmann-La Roche Intervention: Glofitamab Start Date: 2018-03-13 Last Updated: 2023-10-11 Number of Patients: 172 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: B-Cell Lymphoma
NCTID: NCT04731610
Title: Randomized, Multicenter, Phase III Trial to Assess Conformal Post-operative Radiotherapy vs. Surveillance After Complete Resection of Stage II/III Thymoma Study Summary: The primary objective of the study : to compare the Recurrence-Free survival (RFS) between arms. RFS is defined as time from randomisation to the first recurrence (either local-regional or distant) or death of any cause. Sponsor: Institut Curie Intervention: Radiotherapy Start Date: 2021-12-28 Last Updated: 2023-11-15 Number of Patients: 314 Recruitment Status: RECRUITING Condition: Thymoma Malignant Recurrent
NCTID: NCT00072462
Title: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ. Sponsor: Queen Mary University of London Intervention: tamoxifen citrate Start Date: 2003-09 Last Updated: 2021-10-06 Number of Patients: 2980 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT02493972
Title: Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis Study Summary: This is a Multicenter prospective diagnostic study. Sponsor: Centre Francois Baclesse Intervention: GelPort Start Date: 2015-09 Last Updated: 2019-07-09 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Ovarian Cancer With Peritoneal Carcinosis
NCTID: NCT03466788
Title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer Study Summary: Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care Sponsor: Centre Francois Baclesse Intervention: Self questionnaires of quality of life and living conditions Start Date: 2018-03-29 Last Updated: 2020-02-07 Number of Patients: 51 Recruitment Status: COMPLETED Condition: Endometrial Cancer
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03212742
Title: Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients Study Summary: The Stupp protocol is the standard treatment of glioblastoma multiform (GBM) which prognosis remains poor. The non-dividing nature of normal brain cells provides an opportunity to enhance the therapeutic ratio by combining radiation with inhibitors of replication-specific DNA repair pathways such poly(ADP-ribose) polymerase (PARP) inhibitors, thus inducing more cytotoxic effects of DNA-damage related to treatment modalities, including alkylating reagents like temozolomide (TMZ). Olaparib, a potent PARP inhibitor, overcomes apoptotic resistance and sensitizes GBM cells for death receptor-mediated apoptosis induced by TRAIL (Tumor necrosis factor-Related Apoptosis Inducing Ligand). Moreover, inhibition of PARP activity increases cellular sensitivity to ionizing radiation: it was even suggested to be more pronounced in tumors than in normal tissue. Lastly, progress in technical imaging and intensity-modulated-radiotherapy (IMRT) techniques provide new possibilities for sparing healthy tissues. Sponsor: Centre Francois Baclesse Intervention: Olaparib Start Date: 2017-09-04 Last Updated: 2023-09-13 Number of Patients: 91 Recruitment Status: RECRUITING Condition: Malignant Gliomas
NCTID: NCT03878342
Title: Radiotherapy Omission in Low Risk Ductal in Situ Carcinoma Breast Study Summary: Following breast-conserving surgery (BCS) for localized ductal carcinoma in situ (DCIS) of the breast, whole-breast irradiation (WBRT) is a standard of care, reducing the absolute rate of in-breast recurrences (IBR) by more than 15% at 10 years, from 28% without radiotherapy to 13 % with radiotherapy. Half of the recurrences occurred as invasive disease. Whereas in the comparative trials, WBRT did not impact on overall survival, survival of patients who recurred with invasive cancers was impaired in comparison to patients who did not recur, or to patients with DCIS-only recurrences. Using criteria based on age, tumor size, nuclear grade, and margins status, several trials and cohort studies failed to identify subgroups of patients at low risk, who could be safely spared the need for WBRT. The Radiation Therapy Oncology Group (RTOG) DCIS trial included patients treated with BCS for low- or intermediate grade DCIS revealed by unifocal microcalcifications, size ≤25 mm, margins ≥3 mm, and no residual microcalcifications after surgery. The 5-year rates of IBR were 3.5 % without radiotherapy, versus 0.4 % with radiotherapy, and 6.7 % and 0.9 % at 7 years, respectively (p <0.001). Sixty percent of the patients received tamoxifen in both groups. Several studies showed that the same molecular classes were identified in DCIS as in invasive cancers. Studies suggested that low proliferation, hormone receptors expression, and lack of ERBB2 amplification were associated with a low risk of IBR in patients not receiving radiotherapy. A combined signature was tested in the Eastern Cooperative Oncology Group (ECOG) trial, showing a 10% IBR rate at ten years in patients with a low-risk. Identifying very low-risk DCIS, using biological markers in addition to the clinical and histological markers of low-risk DCIS, could help to select patients who could be safely avoided WBRT following BCS. It would avoid over-treatment in these women and could decrease the cost of management. Sponsor: UNICANCER Intervention: Radiotherapy Start Date: 2019-05-10 Last Updated: 2022-08-02 Number of Patients: 300 Recruitment Status: RECRUITING Condition: DCIS
NCTID: NCT00657488
Title: Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma Study Summary: The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment. Sponsor: Celgene Intervention: Thalidomide Start Date: 2001-12-01 Last Updated: 2019-10-18 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT00005589
Title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin’s lymphoma. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin’s lymphoma. Sponsor: EBMT Solid Tumors Working Party Intervention: filgrastim Start Date: 1999-10 Last Updated: 2013-09-17 Number of Patients: 460 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01772472
Title: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) Study Summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Sponsor: Hoffmann-La Roche Intervention: trastuzumab Start Date: 2013-04-03 Last Updated: 2023-11-13 Number of Patients: 1487 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01611142
Title: Study of KW-0761 (Mogamulizumab) in Subjects With Previously Treated Peripheral T-cell Lymphoma (PTCL) Study Summary: The primary objective of this study is to determine the overall response rate of KW-0761 for the treatment of patients with relapsed or refractory PTCL. KW-0761 targets CCR4. CCR4 is the receptor for macrophage derived chemokines MDC/CCL22 and TARC/CCL17. Chemokines are considered to play a role both in the recruitment of immune and inflammatory cells for anti-tumor response and in the selective homing of neoplastic B and T cells. Sponsor: Kyowa Hakko Kirin Pharma, Inc. Intervention: KW-0761 (mogamulizumab) Start Date: 2012-04 Last Updated: 2016-06-14 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Peripheral T-Cell Lymphoma
NCTID: NCT02733042
Title: A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia Study Summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL). Sponsor: Celgene Intervention: Durvalumab Start Date: 2016-05-11 Last Updated: 2023-11-18 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT02242942
Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Study Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years. Sponsor: Hoffmann-La Roche Intervention: Chlorambucil Start Date: 2014-12-31 Last Updated: 2023-09-21 Number of Patients: 445 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphocytic Leukemia, Chronic
NCTID: NCT00287846
Title: Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis Study Summary: RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis. Sponsor: UNICANCER Intervention: imatinib mesylate Start Date: 2004-09 Last Updated: 2016-08-30 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Desmoid Tumor
NCTID: NCT01837251
Title: Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer Study Summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin. Sponsor: AGO Research GmbH Intervention: Carboplatin Start Date: 2013-05 Last Updated: 2021-07-13 Number of Patients: 682 Recruitment Status: COMPLETED Condition: Recurrent Platinum-sensitive Ovarian Cancer
NCTID: NCT04662255
Title: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Study Summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-04-08 Last Updated: 2023-10-04 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT03299855
Title: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric? Study Summary: This study concerns elderly patients with cancer with onco-geriatric assessment. This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment. Sponsor: Centre Francois Baclesse Intervention: Passation of neuropsychological test Start Date: 2017-10-13 Last Updated: 2023-10-18 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT04401748
Title: Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome Study Summary: Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person’s bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires. Sponsor: AbbVie Intervention: Venetoclax Start Date: 2020-09-10 Last Updated: 2023-04-26 Number of Patients: 531 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelodysplastic Syndrome (MDS)
NCTID: NCT02875548
Title: A Study to Assess the Long-term Safety of Tazemetostat Study Summary: This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat. Sponsor: Epizyme, Inc. Intervention: Tazemetostat Start Date: 2016-08-30 Last Updated: 2023-10-26 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma (DLBCL)
NCTID: NCT01842321
Title: Abiraterone Acetate in Molecular Apocrine Breast Cancer Study Summary: The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer. Sponsor: UNICANCER Intervention: Abiraterone Acetate Start Date: 2013-07 Last Updated: 2021-02-23 Number of Patients: 34 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00179621
Title: Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality Study Summary: The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q<math display="block">31</math> cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML). Sponsor: Celgene Corporation Intervention: Lenalidomide 5 mg Start Date: 2005-07 Last Updated: 2011-04-14 Number of Patients: 205 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT00212121
Title: Radiation Dose Intensity Study in Breast Cancer in Young Women Study Summary: hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis. Sponsor: The Netherlands Cancer Institute Intervention: high dose boost Start Date: 2004-07 Last Updated: 2022-01-21 Number of Patients: 2400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04123366
Title: Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors. Sponsor: Merck Sharp & Dohme LLC Intervention: Olaparib Start Date: 2019-11-18 Last Updated: 2023-06-15 Number of Patients: 300 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT01363466
Title: Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer Study Summary: GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays). Sponsor: UNICANCER Intervention: hysterectomy Start Date: 2003-05 Last Updated: 2011-06-01 Number of Patients: 61 Recruitment Status: TERMINATED Condition: Stage IB2 Cervical Cancer
NCTID: NCT05329766
Title: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies Study Summary: This is a Phase 2, open-label, parallel 3-cohort, multicenter study to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Sponsor: Arcus Biosciences, Inc. Intervention: Domvanalimab Start Date: 2022-06-10 Last Updated: 2023-08-31 Number of Patients: 200 Recruitment Status: RECRUITING Condition: Gastrointestinal Tract Malignancies
NCTID: NCT04074330
Title: A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma Study Summary: This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are: * To check for side effects from treatment with TAK-981 given with rituximab. * To check how much TAK-981 participants can tolerate. * To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons. Sponsor: Takeda Intervention: TAK-981 Start Date: 2019-10-15 Last Updated: 2023-05-11 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT02197221
Title: Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma Study Summary: Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy. Sponsor: University Hospital, Toulouse Intervention: Bortezomib-Melphalan Start Date: 2015-01 Last Updated: 2022-05-23 Number of Patients: 300 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01059630
Title: A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (GADOLIN) Study Summary: This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin’s lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years’ safety follow-up from last dose). Sponsor: Genentech, Inc. Intervention: Obinutuzumab Start Date: 2010-04-30 Last Updated: 2020-01-13 Number of Patients: 413 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT03832348
Title: Dynamics of 18-FDG Uptake in Stage III/IV Non Small Cell Lung Cancer During First Line Pembrolizumab Treatment Study Summary: The aim of this study is to describe the early dynamics of 18-FDG uptake in non smal cell lung cancer during first line treatment with pembrolizumab, and to evaluate whether or not they differ according to treatment response at 3 months. Sponsor: Centre Henri Becquerel Intervention: PET scan imaging Start Date: 2019-06-17 Last Updated: 2020-07-30 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT01568866
Title: Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients Study Summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2012-06-20 Last Updated: 2022-11-14 Number of Patients: 929 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT02937948
Title: Adaptative Radiotherapy for Locally Advanced Cervical Cancer Study Summary: This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy. Sponsor: Center Eugene Marquis Intervention: Adaptative treatment plan Start Date: 2017-04-05 Last Updated: 2022-09-02 Number of Patients: 85 Recruitment Status: COMPLETED Condition: Uterine Cervical Cancer
NCTID: NCT00090051
Title: FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients Study Summary: The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2003-07-31 Last Updated: 2017-08-01 Number of Patients: 552 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01391351
Title: Search for Predictors of Therapeutic Response in Ovarian Carcinoma Study Summary: In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months). Sponsor: Centre Francois Baclesse Intervention: blood samples Start Date: 2011-06 Last Updated: 2016-07-21 Number of Patients: 107 Recruitment Status: COMPLETED Condition: Carcinoma of the Ovary
NCTID: NCT02290951
Title: Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies Study Summary: This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL. Sponsor: Regeneron Pharmaceuticals Intervention: Odronextamab multiple dose levels Start Date: 2015-01-09 Last Updated: 2023-09-07 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Hodgkin Lymphoma
NCTID: NCT03897166
Title: Trimodal Imaging Before Radiotherapy Study Summary: In oncology, personalized medicine is progressing by providing increasingly tumor- and patient-specific care. Thus, medical imaging allows precise morphological and functional characterization of the tumor by volume measurements, used in particular in radiotherapy to define the macroscopic tumor volume (GTV), and radiomic measurements that correspond to a recent concept of extraction of textural parameters and/or tumor shape (tumor heterogeneity, tumor invasiveness…). Precise characterization of the patient is also possible by anthropometric measurements (measurements of total muscle mass, visceral adipose tissue mass…) which can be important predictive and prognostic factors and which are generally estimated more accurately in imaging than by using mathematical formulas. However, these measurements are partly dependent on the imaging acquisition mode (PET, CT or MRI). The volume measurements, and therefore the GTV, are thus different depending on the imaging used. Studying these differences is important because no single imaging technique encompasses all potential GTV regions but, on the other hand, a combination of anatomical and functional information could improve tumor delineation. Beyond this volume analysis, the extraction of radiomic characteristics seems very promising in radiotherapy with however many limitations to be overcome, linked in particular to the data acquisition mode. Concerning anthropometric measurements, CT and MRI have become essential techniques for precise anatomical quantification, particularly of lean mass, visceral adipose tissue or muscle mass, but automatic measurement techniques for these parameters have yet to be defined, particularly during CT or MRI acquisitions associated with PET for attenuation correction. To identify useful volume, radiomic and anthropometric characteristics, medical imaging thus requires prospective cohorts of patients with comparable cancer histologies and standardized images acquired by different modalities (e. g. PET, CT or MRI) during the pre-treatment assessment before similar treatments. The purpose of this study is to create a prospective cohort to study volume, radiomic and anthropometric characteristics by taking advantage of the recent installation of MRI in the medical imaging department of the Henri Becquerel Cancer Center (HBCC), Rouen, France, allowing PET/MRI to be performed and by taking advantage of the collaboration between the radiotherapy and medical imaging departments of the HBCC. Sponsor: Centre Henri Becquerel Intervention: Trimodality Start Date: 2019-01-15 Last Updated: 2023-05-03 Number of Patients: 56 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT02303119
Title: Follicular Lymphoma IV/SC Rituximab Therapy (FLIRT) Study Summary: Patient will receive either one infusion of rituximab IV and seven administrations of rituximab SC (experimental arm) or four infusions of rituximab IV (standard arm). The hypothesis is that the use of rituximab by sub cutaneous route and the scheme of administration could: * optimize rituximab exposure leading to improve response rate * increase adaptative response and then improve long-term control disease. Sponsor: The Lymphoma Academic Research Organisation Intervention: Rituximab IV Start Date: 2015-02-02 Last Updated: 2023-01-10 Number of Patients: 221 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT02928419
Title: Efficacy of Eltrombopag Plus Lenalidomide Combination Therapy in Patients With IPSS Low and Intermediate-risk Myelodysplastic Syndrome With Isolated del5q Study Summary: Myelodysplastic syndromes (MDS) prevail in elderly patients and are characterized by inefficient erythropoiesis and peripheral cytopenias. Supportive care still represents the main therapeutic option in most patients. Quality of life is deteriorated mostly by anemia and by limitations due to dependence on transfusions, thrombocytopenia, and neutropenia. The only treatment available for severe thrombocytopenia consists of PLT transfusions, mainly in the presence of bleeding. In patients with low and intermediate-1 risk MDS with an isolated deletion 5q cytogenetic abnormality, red blood cell (RBC) transfusion-dependence is a prevalent condition. For these latter patients reaching transfusion-dependence, lenalidomide, an immunomodulatory drug, has been approved by FDA and EMA. It has been shown that the drug induces significant erythroid (about 65%) and cytogenetic responses which have been associated with a survival benefit. In patients with MDS with del5q and serum erythropoietin levels > 500 miU/L, lenalidomide dosing of 10 mg/day for 21 days every 28, rather than 5 mg dosing, induces higher rates of transfusion-independence and cytogenetic responses with a trend to survival advantage. As a consequence, the recommended starting dose of lenalidomide is 10 mg orally once daily on days 1-21 of repeated 28-day cycles. Lenalidomide treatment must not be started if the Absolute Neutrophil Counts (ANC) < 0.5 Gi/L and/or PLT counts < 25 Gi/L. For patients who are dosed initially at 10 mg and who experience thrombocytopenia < 25 Gi/L (45-75%), it is recommended to interrupt lenalidomide treatment until PLT count returns to ≥ 25 Gi/L on at least 2 occasions for ≥ 7 days or when the PLT count recovers to ≥ 50 Gi/L at any time, to resume lenalidomide at 50% dose reduction. Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS. Preliminary results of an ongoing randomized trial, EQoL-MDS, for the evaluation of efficacy, safety of eltrombopag for thrombocytopenia of low and intermediate-1 IPSS risk MDS has shown that eltrombopag is able to significantly raise PLT counts in about 65% of patients without additional toxicity Furthermore, the combination of lenalidomide and eltrombopag resulted in significant inhibitory effects on the growth of leukemic colonies in the majority of primary MDS and AML samples. Most importantly, eltrombopag was able to reverse the anti-megakaryopoietic effects of lenalidomide in primary MDS patient samples. These results provide a preclinical rationale for the use of this combination in MDS and AML Sponsor: Associazione Qol-one Intervention: Eltrombopag/Revolade Start Date: 2015-05 Last Updated: 2018-09-25 Number of Patients: 2 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndromes
NCTID: NCT00873119
Title: Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary Study Summary: The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary. Sponsor: Onxeo Intervention: belinostat, carboplatin, paclitaxel Start Date: 2009-02 Last Updated: 2015-07-28 Number of Patients: 89 Recruitment Status: COMPLETED Condition: Carcinoma of Unknown Primary
NCTID: NCT01687387
Title: Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR) Study Summary: Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission Sponsor: Innate Pharma Intervention: IPH2102 at 0.1 mg/kg Start Date: 2012-10 Last Updated: 2019-02-08 Number of Patients: 152 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03616886
Title: Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Study Summary: The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach. CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade. The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab <math display="block">anti-PD-L1</math> +/- MEDI9447 <math display="block">anti-CD73</math>) in previously untreated locally recurrent inoperable or metastatic TNBC. A large translational research program is planned including baseline and dynamic biomarkers Sponsor: Jules Bordet Institute Intervention: Paclitaxel Start Date: 2018-12-28 Last Updated: 2023-09-21 Number of Patients: 129 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Cancer
NCTID: NCT01195714
Title: Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years Study Summary: This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4. The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal). Patients will be recruited over 30 months and followed at least one year after the last patient has been included. The duration of the treatment period is approximately 20 weeks. Sponsor: The Lymphoma Academic Research Organisation Intervention: Ofatumumab Start Date: 2010-05 Last Updated: 2018-03-07 Number of Patients: 120 Recruitment Status: COMPLETED Condition: Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
NCTID: NCT02551237
Title: Neoadjuvant Treatment for Advanced Rectal Carcinoma Study Summary: The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL). Sponsor: UNICANCER Intervention: 50 Gy Start Date: 2016-01-07 Last Updated: 2023-10-13 Number of Patients: 103 Recruitment Status: COMPLETED Condition: Rectal Carcinoma
NCTID: NCT03366272
Title: Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients Study Summary: This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma Sponsor: Universität des Saarlandes Intervention: Nivolumab Start Date: 2017-12-05 Last Updated: 2023-11-24 Number of Patients: 348 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Non-Hodgkin
NCTID: NCT06141772
Title: Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy Study Summary: The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline. Sponsor: Centre Henri Becquerel Intervention: Measure of the circulating tumor DNA Start Date: 2023-11-15 Last Updated: 2023-11-21 Number of Patients: 12 Recruitment Status: NOT_YET_RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT00216372
Title: Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis Study Summary: The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis. Sponsor: Ipsen Intervention: Lanreotide (microparticle formulation) Start Date: 2003-09 Last Updated: 2020-11-05 Number of Patients: 80 Recruitment Status: COMPLETED Condition: Intestinal Obstruction
NCTID: NCT01414933
Title: High Throughput Technologies to Drive Breast Cancer Patients to Specific Phase I/II Trials of Targeted Agents Study Summary: High sensitivity to targeted agents has been observed in patients whose tumor cells present a genetic/genomic deregulation of the target (Kit mutation, ERBB2 amplification, EGFR mutations) together with addiction to the given target. More recently, activation of “alternative pathways” (Kras mutation, PI3K mutations) have been reported as a common resistance mechanism to single agent tyrosine kinase inhibitors (trastuzumab, cetuximab). From these data has emerged the hypothesis that identification of the deregulated pathway through new molecular tools could allow to propose a more tailored targeted regimen. Based on these concepts, numbers of phase I/II trials enrich their populations in patients presenting specific molecular alterations. High throughput technologies (array CGH, sequencing, gene expression array) identify deregulated genes. In addition, these technologies determine whether such genomic alterations are single (expected efficacy of single agent) or multiple (rationale for combination). In a pilot study that included 135 patients, we recently performed a combination of array CGH and hot spot mutation array in order to drive patients into phase I/II clinical trials. This study led to the conclusions that high throughput technologies i. are feasible (80%) and robust, ii. identify “targetable” genomic alterations in around 40% of samples. In the present study, the investigators will perform high throughput technologies to drive 400 metastatic breast cancer patients into specific phase I/II trials. Sponsor: UNICANCER Intervention: Biopsy Start Date: 2011-05 Last Updated: 2017-05-04 Number of Patients: 423 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT01518517
Title: GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia Study Summary: Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane. This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase. Sponsor: ERYtech Pharma Intervention: GRASPA Start Date: 2009-12 Last Updated: 2022-02-02 Number of Patients: 85 Recruitment Status: COMPLETED Condition: Acute Lymphoblastic Leukemia, in Relapse
NCTID: NCT03274492
Title: A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma Study Summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL). Sponsor: Hoffmann-La Roche Intervention: Polatuzumab Vedotin Start Date: 2017-11-16 Last Updated: 2023-11-24 Number of Patients: 1000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT00450892
Title: Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: docetaxel+lapatinib Start Date: 2007-02 Last Updated: 2016-07-07 Number of Patients: 129 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00140660
Title: ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma Study Summary: This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma. Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2003-12 Last Updated: 2017-03-13 Number of Patients: 223 Recruitment Status: TERMINATED Condition: Diffuse Large Cell Lymphoma
NCTID: NCT00049660
Title: Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if capecitabine is more effective than vinorelbine in treating metastatic breast cancer. PURPOSE: Randomized phase II/III trial to compare the effectiveness of capecitabine with that of vinorelbine in treating women who have metastatic breast cancer that has been previously treated with chemotherapy. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: capecitabine Start Date: 2002-09 Last Updated: 2012-07-18 Number of Patients: 47 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT00136565
Title: Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma Study Summary: The purpose of this study is to determine the efficacy and the safety profile and toxicity of a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP <math display="block">doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone</math>) in the treatment of previously untreated patients with peripheral T-cell lymphoma (PTCL). Sponsor: Lymphoma Study Association Intervention: Velcade Start Date: 2006-01-08 Last Updated: 2018-08-23 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Peripheral T-cell Lymphoma
NCTID: NCT05020665
Title: A Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia Study Summary: The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD). Sponsor: Kronos Bio Intervention: Entospletinib Start Date: 2021-11-30 Last Updated: 2023-06-12 Number of Patients: 15 Recruitment Status: TERMINATED Condition: Nucleophosmin 1-mutated Acute Myeloid Leukemia
NCTID: NCT00169130
Title: ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma Study Summary: The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years. Sponsor: Lymphoma Study Association Intervention: doxorubicin Start Date: 1999-10 Last Updated: 2007-07-13 Number of Patients: 300 Recruitment Status: COMPLETED Condition: Lymphoma, Large-Cell, Diffuse
NCTID: NCT04261153
Title: Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study Study Summary: Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface. Sponsor: Centre Francois Baclesse Intervention: Cognitive stimulation Start Date: 2020-06-05 Last Updated: 2023-08-01 Number of Patients: 55 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT01026142
Title: A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA) Study Summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: Capecitabine Start Date: 2010-01-26 Last Updated: 2018-08-14 Number of Patients: 452 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT01100502
Title: A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) Study Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT). Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2010-04-30 Last Updated: 2021-05-14 Number of Patients: 329 Recruitment Status: COMPLETED Condition: Disease, Hodgkin
NCTID: NCT05590702
Title: French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings Study Summary: Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation. We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome. Sponsor: French Innovative Leukemia Organisation Intervention: First line therapy Start Date: 2022-11-11 Last Updated: 2023-03-20 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: CLL/SLL
NCTID: NCT01427478
Title: Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck Study Summary: The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck. Sponsor: Centre Leon Berard Intervention: AFATINIB Start Date: 2011-09 Last Updated: 2021-06-01 Number of Patients: 134 Recruitment Status: COMPLETED Condition: Head and Neck Squamous Cell Carcinoma
NCTID: NCT01971658
Title: Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04) Study Summary: This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma. Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD. Sponsor: Nantes University Hospital Intervention: Thalidomide® Start Date: 2013-10 Last Updated: 2015-10-07 Number of Patients: 358 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT04307277
Title: Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma Study Summary: Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature. After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened). Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort). Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms: * Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy). * Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks. A total of 250 patients will have to be randomized with 125 patients in each arm. Sponsor: Institut Claudius Regaud Intervention: Standard of care + chemotherapy Start Date: 2020-10-09 Last Updated: 2023-02-27 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Soft Tissue Sarcoma
NCTID: NCT01358877
Title: A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer Study Summary: This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil Start Date: 2011-11-08 Last Updated: 2023-10-04 Number of Patients: 4804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04628494
Title: A Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in R/R DLBCL Study Summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator’s choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT Sponsor: Genmab Intervention: Epcoritamab Start Date: 2021-01-13 Last Updated: 2023-08-07 Number of Patients: 552 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02631577
Title: A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma Study Summary: This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A) [TECENTRIQ] Start Date: 2015-12-31 Last Updated: 2022-04-13 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Lymphoma, Follicular
NCTID: NCT03104478
Title: Real Time Molecular Characterization of Diffuse Large B Cell Lymphoma (DLBCL) Study Summary: The trial will enroll 194 previously untreated DLBCL patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by D38 in at least 80% of enrolled patients. The feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms. Sponsor: The Lymphoma Academic Research Organisation Intervention: Biological samples collection Start Date: 2017-05-09 Last Updated: 2021-12-07 Number of Patients: 219 Recruitment Status: COMPLETED Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT01303094
Title: Continuing vs Intermittent Trabectedin in Patients With Advanced Soft Tissue Sarcoma Study Summary: This randomization discontinuation trial will allow for concomitant evaluation of the following: * Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle * Side effects and benefits of a drug holiday Sponsor: Centre Oscar Lambret Intervention: Trabectedin Start Date: 2011-02 Last Updated: 2019-05-31 Number of Patients: 53 Recruitment Status: COMPLETED Condition: Soft Tissue Sarcoma
NCTID: NCT03593018
Title: Efficacy and Safety of Oral Azacitidine Compared to Investigator’s Choice Therapy in Patients With Relapsed or Refractory AITL Study Summary: This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator’s Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma. Sponsor: The Lymphoma Academic Research Organisation Intervention: Oral azacitidine Start Date: 2018-11-09 Last Updated: 2023-03-29 Number of Patients: 86 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed Angioimmunoblastic T-Cell Lymphoma
NCTID: NCT04569032
Title: A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression Study Summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2020-11-12 Last Updated: 2023-11-14 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Peripheral T-cell Lymphoma
NCTID: NCT04745832
Title: Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL) Study Summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL. Sponsor: MEI Pharma, Inc. Intervention: Zandelisib Start Date: 2021-08-13 Last Updated: 2023-05-09 Number of Patients: 82 Recruitment Status: TERMINATED Condition: Follicular Lymphoma (FL)
NCTID: NCT06027632
Title: Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer Study Summary: Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment. The research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation/adherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone. Sponsor: Centre Francois Baclesse Intervention: Cognitive exercises with supervision Start Date: 2023-09 Last Updated: 2023-09-13 Number of Patients: 300 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Cancer
NCTID: NCT00022594
Title: Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: liposomal lurtotecan Start Date: 2001-05 Last Updated: 2012-07-24 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Head and Neck Cancer
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT01788618
Title: Cancer and Disorders of Cognitive Functions and Quality of Life: “Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy” Study Summary: Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint Sponsor: Centre Francois Baclesse Intervention: Cognitive exams Start Date: 2012-07 Last Updated: 2017-07-28 Number of Patients: 168 Recruitment Status: COMPLETED Condition: Cancer
NCTID: NCT00140595
Title: ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1 Study Summary: This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI). Sponsor: Lymphoma Study Association Intervention: rituximab Start Date: 2003-12 Last Updated: 2011-03-04 Number of Patients: 380 Recruitment Status: COMPLETED Condition: Diffuse Large-Cell Lymphoma
NCTID: NCT01576796
Title: Radiotherapy Dose Complement in the Treatment of Hypoxic Lesions Patients With Stage III Non-small-cell Lung Cancer Study Summary: This study will assess the efficacy and safety of a radiotherapy dose complement (boost) in the treatment of hypoxic lesions, measured by F-miso PET/CT, in patients with stage III NSCLC not amenable to surgery and candidate for chemoradiotherapy. Preliminary studies in head and neck cancers have demonstrated the feasibility and support the medical benefit of this novel approach. The aim of the study is to assess the efficacy and safety of a radiotherapy dose complement (boost) in this difficult medical condition for which only limited treatment options are available. Sponsor: Centre Henri Becquerel Intervention: Radiotherapy Start Date: 2012-03 Last Updated: 2016-07-28 Number of Patients: 75 Recruitment Status: UNKNOWN Condition: Stage III Non-small-cell Lung Cancer
NCTID: NCT05260528
Title: CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics Study Summary: The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria) Sponsor: Centre Hospitalier Universitaire de Nice Intervention: Cytarabine and Idarubicin Start Date: 2023-05-03 Last Updated: 2023-07-11 Number of Patients: 210 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT05183984
Title: Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer Study Summary: Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab. Sponsor: ARCAGY/ GINECO GROUP Intervention: Chemotherapy Start Date: 2022-02-01 Last Updated: 2022-12-06 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Ovarian Cancer
NCTID: NCT01461928
Title: A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab Study Summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin’s lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter <math display="block">mg/m\^2</math> intravenously <math display="block">IV</math> in Cycle 1, then 1400 mg subcutaneous <math display="block">SC</math> every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Chemotherapy (Induction Period) Start Date: 2011-12-20 Last Updated: 2019-08-06 Number of Patients: 692 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT00003028
Title: MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: sabarubicin Start Date: 1997-04 Last Updated: 2012-07-02 Number of Patients: 5 Recruitment Status: COMPLETED Condition: Unspecified Adult Solid Tumor, Protocol Specific
NCTID: NCT01208896
Title: Allogeneic Hematopoietic Stem Cell Transplantation After Reduced-intensity Conditioning for Relapsed Follicular Lymphoma Study Summary: This trial will evaluate the efficacy and the safety of a strategy of allogeneic stem cell transplantation including Rituximab in the conditioning regimen for the treatment of relapsed follicular lymphoma. The rationale for using Rituximab relies on a better control of the disease and a better prophylaxis of the graft versus host disease. Sponsor: University Hospital, Bordeaux Intervention: Reduced_intensity conditioning Start Date: 2011-02-03 Last Updated: 2018-08-09 Number of Patients: 32 Recruitment Status: COMPLETED Condition: Lymphoma, Follicular
NCTID: NCT01956695
Title: Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma Study Summary: Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin’s lymphoma (NHL) could be observed in PCNSL. This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response. Sponsor: Institut Curie Intervention: Lenalidomide Start Date: 2013-09-18 Last Updated: 2020-12-17 Number of Patients: 45 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT00002462
Title: RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin’s Disease Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin’s disease. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1989-09 Last Updated: 2023-02-15 Number of Patients: 615 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT02507518
Title: Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer Study Summary: Non small cell lung cancer is the first cause of cancer related death in France and is becoming an increasing health problem in developing countries. Recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival. Until now, determination of efficiency of treatment is only based on morphological response (RECIST) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification. Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a biologically relevant tool for assessment of tumour response therapies. The assumption of the study is that FDG PET would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment is maintained up to evidence of progression disease. However, despite the increasing use of FDG PET for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer. It seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer. The final aim is to optimize survival by an adapted metabolic imaging guided therapy. Sponsor: Centre Henri Becquerel Intervention: PET scan imaging Start Date: 2013-12 Last Updated: 2018-07-23 Number of Patients: 80 Recruitment Status: UNKNOWN Condition: Non-small Cell Lung Cancer
NCTID: NCT02821936
Title: Parametric Imaging in Positron Emission Tomography for Patient With Lung Cancer Study Summary: The purpose of this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy. The ancillary study will evaluate the interest of parametric PET imaging during the treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment re-planification or intensification (not realized on the present study). Sponsor: Centre Henri Becquerel Intervention: Parametric Imaging Start Date: 2016-05 Last Updated: 2018-07-24 Number of Patients: 40 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer
NCTID: NCT00870701
Title: Observation Versus Post-surgery Radiotherapy After Complete Exeresis in Soft Tissues Members Sarcoma Study Summary: Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them. These rare tumors involve complex multidisciplinary care better in centers having expertise. Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival. The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%. The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order. Sponsor: Institut Claudius Regaud Intervention: Radiotherapy Start Date: 2009-03-19 Last Updated: 2018-08-22 Number of Patients: 77 Recruitment Status: TERMINATED Condition: Soft Tissue Sarcoma of Members
NCTID: NCT04031534
Title: Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma Study Summary: Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia. Sponsor: Centre Henri Becquerel Intervention: F-Miso PET scan coupled with MRI Start Date: 2019-03-21 Last Updated: 2020-07-30 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Squamous Cell Carcinoma of the Oropharynx
NCTID: NCT03677141
Title: A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma Study Summary: This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (DLBCL). Sponsor: Hoffmann-La Roche Intervention: Mosunetuzumab Start Date: 2019-03-08 Last Updated: 2023-11-09 Number of Patients: 117 Recruitment Status: COMPLETED Condition: B-cell Non-Hodgkin Lymphoma
NCTID: NCT00413036
Title: A Study of Revlimid in the Treatment of Non-Hodgkin’s Lymphoma Study Summary: Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop Sponsor: Celgene Intervention: lenalidomide Start Date: 2006-06 Last Updated: 2017-03-01 Number of Patients: 217 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin’s
NCTID: NCT00381901
Title: Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery Study Summary: RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer. PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery. Sponsor: National Cancer Institute, France Intervention: trastuzumab Start Date: 2006-05 Last Updated: 2011-05-13 Number of Patients: 3400 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00066378
Title: Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer Study Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: anastrozole Start Date: 2003-05 Last Updated: 2013-10-24 Number of Patients: 71 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT04895358
Title: Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) Study Summary: The safety and efficacy of pembrolizumab plus the investigator’s choice of chemotherapy will be assessed compared to placebo plus the investigator’s choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2021-06-18 Last Updated: 2023-11-27 Number of Patients: 800 Recruitment Status: RECRUITING Condition: Breast Neoplasms
NCTID: NCT02889523
Title: Study of Tazemetostat in Newly Diagnosed Diffuse Large B Cell and Follicular Lymphoma Patients Treated by Chemiotherapy Study Summary: Phase I of the study is designed to determine the recommended phase II dose (RP2D) for tazemetostat in patients treated with 8 cycles of R-CHOP 21. Phase II of the study is designed to determine the safety and the efficacy of tazemetostat in DLBCL and FL patients : DLBCL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab FL : tazemetostat with 6 cycles of R-CHOP 21 + 2 cycles of Rituximab then maintenance with 6 months of tazemetostat and 24 months of Rituximab Sponsor: The Lymphoma Academic Research Organisation Intervention: Tazemetostat Start Date: 2016-10 Last Updated: 2023-03-17 Number of Patients: 214 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT01833884
Title: Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic Study Summary: More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless, some patients relapse and others are resistant to any treatment. These patients represent 2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International Prognostic Score) cannot always detect patients at risk. New prognostic factors are required to screen out these high risk patients. Among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment. Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team published the prognostic value of the decrease of TARC (CC Thymus and Activation-related chemokine). In daily practice, the early assessment of response by PET CT-scan is now an undeniable prognostic factor. Early identification of no-response or relapse is, in fact, based on clinical and imaging (PET-CT scan). We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up. The dosage of these cytokines will be paired with radiological assessments. A correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards. Sponsor: Centre Henri Becquerel Intervention: Collection of blood specimen Start Date: 2010-04 Last Updated: 2017-07-21 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Hodgkin’s Disease
NCTID: NCT01021423
Title: A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). Study Summary: A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2010-04-01 Last Updated: 2019-11-19 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Mantle Cell Lymphoma
NCTID: NCT01510184
Title: Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy Study Summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. Sponsor: Spectrum Pharmaceuticals, Inc Intervention: Zevalin Start Date: 2012-04-19 Last Updated: 2021-12-16 Number of Patients: 79 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT02503423
Title: Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas Study Summary: This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available. Sponsor: Astex Pharmaceuticals, Inc. Intervention: ASTX660 Start Date: 2015-07 Last Updated: 2023-09-01 Number of Patients: 230 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumors
NCTID: NCT00005584
Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin’s Lymphoma Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin’s lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin’s lymphoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: bleomycin sulfate Start Date: 1998-10 Last Updated: 2023-02-15 Number of Patients: 1649 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT01098084
Title: Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML) Study Summary: The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Decitabine Start Date: 2008-11 Last Updated: 2014-03-20 Number of Patients: 41 Recruitment Status: COMPLETED Condition: Chronic Myelomonocytic Leukemia
NCTID: NCT00470223
Title: Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma. PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma. Sponsor: UNICANCER Intervention: cisplatin Start Date: 2007-03 Last Updated: 2022-06-27 Number of Patients: 318 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Sarcoma
NCTID: NCT02515084
Title: Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma Study Summary: The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma. Sponsor: Centre Henri Becquerel Intervention: PET Start Date: 2011-03 Last Updated: 2016-08-24 Number of Patients: 37 Recruitment Status: COMPLETED Condition: Thyroid Cancer
NCTID: NCT05272358
Title: Economic Evaluation of Sarcoma Patients Management in France Study Summary: The aim of this project is to (1) evaluate the efficiency of early management of sarcoma patients by the sarcoma referral network (NETSARC) vs. outside the network; (2) measure the budgetary impact of the generalization of the most cost-effective strategy across the country; (3) identify the organizational and financial constraints likely to hinder the generalization of the most cost-effective strategy and propose solutions, and finally (4) analyse the budgetary impact of a generalization of sarcoma patient care by the reference network by integrating the organizational and financial solutions proposed. The study relies on an exhaustive national cohort of all sarcoma patients who underwent primary tumor surgery for the year 2013. Patients will be allocated to four distinct strategies, each representing a different management of sarcoma patients who had a sarcoma-specialized multidisciplinary tumor board (MDTB) before the initial surgery and complete initial management in the network (strategy 1); patients who had a sarcoma-specialized MDTB before the initial surgery and initial management outside the network (strategy 2); patients who had a sarcoma-specialized MDTB after initial surgery and initial management outside the network (strategy 3); patients who had an initial management outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4). Matching of the National Health Data System (SNDS) and the NETSARC databases made it possible to include 2431 patients in the study. These databases will allow to obtain information on patients, estimate overall survival and identify healthcare consumption, which will be useful in achieving study’s objectives. Sponsor: Centre Leon Berard Intervention: NETSARC network Start Date: 2021-02-08 Last Updated: 2022-03-09 Number of Patients: 2431 Recruitment Status: RECRUITING Condition: Sarcoma
NCTID: NCT06089941
Title: Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas Study Summary: The purpose of this study is to assess the feasibility of analyzing circulating tumor DNA (ctDNA) as a biomarker using the shallow whole genome sequencing (lpWGS) technique coupled with deep sequencing of a targeted panel of genes (NGS), in a population of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma (PTCL). Sponsor: Centre Henri Becquerel Intervention: circulating tumoral DNA detection Start Date: 2023-11-02 Last Updated: 2023-10-19 Number of Patients: 45 Recruitment Status: NOT_YET_RECRUITING Condition: Peripheral T Cell Lymphoma
NCTID: NCT03386734
Title: International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer Study Summary: SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This “validation study” will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a “quality assurance” program which will be developed in participating centers with detailed requirements in terms of surgeons’ qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the “safety algorithm”. Sponsor: Centre Hospitalier Universitaire de Besancon Intervention: SLN biopsy only Start Date: 2018-05-03 Last Updated: 2022-07-28 Number of Patients: 988 Recruitment Status: RECRUITING Condition: Cervical Cancer
NCTID: NCT00689936
Title: Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma Study Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide. Sponsor: Celgene Intervention: Lenalidomide and low-dose dexamethasone Start Date: 2008-08-21 Last Updated: 2019-11-20 Number of Patients: 1623 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT00005980
Title: Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: pegylated liposomal doxorubicin hydrochloride Start Date: 2000-04 Last Updated: 2012-07-18 Number of Patients: 116 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00104624
Title: Docetaxel in Treating Older Women With Metastatic Breast Cancer Study Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities. Sponsor: UNICANCER Intervention: docetaxel Start Date: 2005-05 Last Updated: 2013-09-04 Number of Patients: 53 Recruitment Status: TERMINATED Condition: Breast Cancer
NCTID: NCT04318080
Title: Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma Study Summary: The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator. Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2020-08-20 Last Updated: 2023-08-25 Number of Patients: 46 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT01551524
Title: Phase I Study of mPEG-R-Crisantaspase Given IV Study Summary: This study is an open label, multicenter study with a dose escalation of Asparec® administered once every two to four weeks for two administrations. The primary objective of this study is to determine the Maximum Tolerated Dose following one single dose of Asparec when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which are to evaluate the safety of Asparec and to determine the PK profile as assessed by measurement of plasma L-asparaginase enzymatic activity following single and repeated doses of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be measured. Sponsor: Jazz Pharmaceuticals Intervention: mPEG-r-crisantaspase Start Date: 2012-03 Last Updated: 2015-05-07 Number of Patients: 36 Recruitment Status: COMPLETED Condition: Hematologic Malignancies
NCTID: NCT01770301
Title: Efficacy and Safety of Bevacizumab (Avastin®) Combined to Weekly Paclitaxel Followed by Bevacizumab (Avastin®) Alone in Patients With Relapsed Ovarian Sex-cord Stromal Tumours (ALIENOR) Study Summary: Bevacizumab (called also Avastin ®) is a medicine preventing the creation of new blood vessels (a process called “angiogenesis”). This can reduce blood flow of the tumor and then decreasing the contribution of nutriments and oxygen to the cancer cells and prevent the tumor from growing. In various types of cancers, as lung, breast, colorectal and renal cancer, addition of the bevacizumab to chemotherapy allowed to improve the disease outcome. The bevacizumab already benefits from a marketing authorization (MMA) for these various types of cancers. The bevacizumab has also obtained MMA for the treatment of the ovarian cancer in its most frequent histological form (ovarian carcinoma). Clinical trials conducted in this indication demonstrated the importance to pursue the treatment by bevacizumab after the chemotherapy is ended. This anti-angiogenic medicine is thought to be of a potential interest in sex cords- stromal since this tumors are very well vascularized. The ALIENOR study aims to explore the interest and the clinical benefit of associating bevacizumab to the paclitaxel in order to treat patients suffering from recurring sex cords- stromal tumor treated beforehand by platinum chemotherapy Sponsor: ARCAGY/ GINECO GROUP Intervention: Paclitaxel Start Date: 2013-02 Last Updated: 2021-07-02 Number of Patients: 60 Recruitment Status: COMPLETED Condition: Ovarian Sex-cord Stromal Tumor
NCTID: NCT01796002
Title: Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma Study Summary: Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC). Sponsor: The Lymphoma Academic Research Organisation Intervention: Romidepsin + CHOP Start Date: 2013-01 Last Updated: 2023-01-10 Number of Patients: 421 Recruitment Status: COMPLETED Condition: Peripheral T-cell Lymphoma
NCTID: NCT02924402
Title: Study to Evaluate Safety and Tolerability of XmAb13676 (Plamotamab) in Patients With CD20-expressing Hematologic Malignancies Study Summary: The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD). Sponsor: Xencor, Inc. Intervention: XmAb13676 Start Date: 2016-10 Last Updated: 2023-03-01 Number of Patients: 270 Recruitment Status: RECRUITING Condition: B-cell Non-Hodgkins Lymphoma
NCTID: NCT04502394
Title: Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy) Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2021-02-23 Last Updated: 2022-08-04 Number of Patients: 84 Recruitment Status: RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT00104741
Title: Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer Study Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer. Sponsor: UNICANCER Intervention: flutamide Start Date: 2003-09-10 Last Updated: 2021-02-21 Number of Patients: 378 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT01835236
Title: Trastuzumab & Pertuzumab Followed by T-DM1 in MBC Study Summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician’s discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer. Sponsor: Swiss Group for Clinical Cancer Research Intervention: Trastuzumab Start Date: 2013-03-03 Last Updated: 2021-03-30 Number of Patients: 208 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT01069796
Title: Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer Study Summary: Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy). Sponsor: ARCAGY/ GINECO GROUP Intervention: Paclitaxel Start Date: 2010-04 Last Updated: 2016-03-17 Number of Patients: 64 Recruitment Status: TERMINATED Condition: Triple Negative Metastatic Breast Cancer
NCTID: NCT03401840
Title: STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03 Study Summary: The main objective of this national, open-label, non-randomized phase II trial is to evaluate severe late toxicity of postoperative hypofractionated stereotactic radiotherapy (SBRT) in the treatment of early stage oropharyngeal and oral cavity cancer with high risk margins. Sponsor: Centre Jean Perrin Intervention: postoperative hypofractionated stereotactic radiotherapy Start Date: 2018-01-23 Last Updated: 2023-03-07 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT05008224
Title: Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11) Study Summary: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-10-07 Last Updated: 2023-10-25 Number of Patients: 146 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Classical Hodgkin Lymphoma
NCTID: NCT01063257
Title: Clofarabine in High Risk Myelodysplastic Syndrome (MDS) Study Summary: This study aims to determine the maximal tolerated dose (MTD) and dose limiting toxicities (DLTs) of low dose IV clofarabine for MDS patients after treatment failure of azacitidine. Sponsor: Groupe Francophone des Myelodysplasies Intervention: Clofarabine Start Date: 2010-04 Last Updated: 2014-03-19 Number of Patients: 76 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndrome
NCTID: NCT04918940
Title: Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma Study Summary: The anti-CD20 monoclonal antibodies, rituximab (R) and obinutuzumab (G), are used as standard maintenance therapy every 2 months for 2 to 3 years in patients with follicular lymphoma (FL) or mantle cell lymphoma (MCL). This treatment is associated with profound and prolonged B lymphopenia, hypogammaglobulinemia and increased infections. Severe forms of COVID-19 on Rituximab with prolonged carriage of the virus have been reported due to significant impairment of humoral immunity in this context of maintenance therapy. Therefore, during the COVID-19 epidemic, clinicians are faced with the question of whether to discontinue maintenance therapy or continue treatment. However, the half-life of rituximab is 29 days and lymphopenia continues for up to 9-12 months after stopping injections. Therefore, it is not clear that discontinuation of maintenance therapy will alter the risk of severe SARS-CoV-2. However, post-vaccination immunization against SARS-CoV-2 by an mRNA vaccine is not known in this context of prolonged treatment with rituximab or obinutuzumab. It is however well established that post-vaccination responses against diphtheria, tetanus, pneumococcus, HBV, or influenza in particular are altered after anti-CD20 antibodies. If the humoral response is crucial in the post-vaccination response, it is also suggested that the preservation of innate immunity and the CD8 response, unaltered by anti-CD20, could also play an important role in the post-vaccination response and virus clearance. The aim of our study is to evaluate the humoral and post-vaccination T-cell response based on serological data and T-cell production of interferon gamma in response to SARS-CoV-2 specific antigens (Elispot interferon gamma) in this group of patients treated for lymphoma with a long-term anti-CD20 antibody. Sponsor: Centre Henri Becquerel Intervention: Determination of COVID-19 vacciantion efficacy Start Date: 2021-05-21 Last Updated: 2022-12-23 Number of Patients: 20 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT01691898
Title: A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma (NHL) Study Summary: This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL). Sponsor: Genentech, Inc. Intervention: Obinutuzumab Start Date: 2012-09-27 Last Updated: 2020-02-21 Number of Patients: 231 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT05858398
Title: Influence of Body Composition on Chemotherapy Outcomes in Localized Breast Cancer Study Summary: The purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the BMI but also by CT-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer Sponsor: Centre Henri Becquerel Intervention: pharmacokinetics blood sample assessment Start Date: 2023-05-30 Last Updated: 2023-05-15 Number of Patients: 48 Recruitment Status: NOT_YET_RECRUITING Condition: Breast Cancer
NCTID: NCT03955198
Title: A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation Study Summary: This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation. Fifty patients will have to be enrolled in this phase II trial. Total duration of treatment will be 12 months. Patients will be followed for a maximum of 2 years following the date of inclusion. Sponsor: Institut Claudius Regaud Intervention: Radiotherapy + durvalumab Start Date: 2021-05-27 Last Updated: 2023-03-01 Number of Patients: 4 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: NSCLC
NCTID: NCT03539744
Title: A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma. Study Summary: A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone. Sponsor: AbbVie Intervention: Pomalidomide Start Date: 2018-10-22 Last Updated: 2023-11-28 Number of Patients: 244 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT00010244
Title: Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer Study Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer. Sponsor: UNICANCER Intervention: radiation therapy Start Date: 1999-09 Last Updated: 2021-02-21 Number of Patients: 306 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03734757
Title: Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Study Summary: The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS). For this type of cancer, reference treatment is radiotherapy combined with hormone therapy. The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography. The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension. It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging. Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy. The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison). In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study. Sponsor: Centre Henri Becquerel Intervention: imaging in trimodality Start Date: 2018-10-16 Last Updated: 2020-07-30 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Prostate Cancer
NCTID: NCT01261598
Title: Predictive Value of FDG-TEP During Radiotherapy or Chemo-radiotherapy in Patients With NCSC on the One-year Survival Study Summary: The poor prognosis in the early-stage of lung cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments. FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after RT or CRT. Our assumption is that an FDG-PET exam during the course of the RT or CRT might be predictive of the treatment efficiency few months later. In this study, the investigators propose to perform 4 FDG-PET: first “PET1” before radiotherapy, second “PET2” during the radiotherapy (see RTEP1), third and fourth “PET3” “PET4” 3month and 12 month after the therapy. The investigators will investigate the performances of FDG-PET performed during the RT or CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, the investigators would be able to optimize the planning treatment during the course of the therapy. Sponsor: Centre Henri Becquerel Intervention: Positron Emission Tomography Start Date: 2007-11 Last Updated: 2016-10-17 Number of Patients: 98 Recruitment Status: COMPLETED Condition: Lung Cancer
NCTID: NCT02477644
Title: Platine, Avastin and OLAparib in 1st Line Study Summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance. Sponsor: Arcagy Research Intervention: Olaparib Start Date: 2015-05-06 Last Updated: 2022-08-02 Number of Patients: 806 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT00534274
Title: Positron Emission Tomography Using 3’-Deoxy-3’-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy Study Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3’-deoxy-3’-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer. PURPOSE: This clinical trial is studying how well positron emission tomography using 3’-deoxy-3’-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy. Sponsor: UNICANCER Intervention: 3’-deoxy-3’-[18F]fluorothymidine Start Date: 2006-11 Last Updated: 2014-12-16 Number of Patients: 97 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT03144674
Title: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) Study Summary: The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2017-12-18 Last Updated: 2023-10-26 Number of Patients: 110 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT03235544
Title: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton’s Tyrosine Kinase (BTK) Inhibitor Study Summary: This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton’s tyrosine kinase (BTK) inhibitor. Sponsor: Incyte Corporation Intervention: Parsaclisib Start Date: 2017-11-20 Last Updated: 2023-11-18 Number of Patients: 162 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma
NCTID: NCT03127995
Title: Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence Study Summary: The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks. Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women. The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments Sponsor: UNICANCER Intervention: HYPOFRACTIONATED Start Date: 2016-09 Last Updated: 2023-02-08 Number of Patients: 1265 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Female
NCTID: NCT02055924
Title: Bruton’s Tyrosine Kinase (BTK) Inhibition in B-cell Lymphomas Study Summary: This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C). During Part 1 Dose Escalation, the “3+3” design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg. The dose escalation will be performed for two types of associations in five separate groups : * Group A : ibrutinib D1-D21+ R-DHAP * Group B : ibrutinib D1-D21 R-DHAOx * Group Abis : ibrutinib D5-D18+ R-DHAP * Group Bbis : ibrutinib D5-D18 R-DHAOx This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient. Sponsor: The Lymphoma Academic Research Organisation Intervention: Ibrutinib and immunochemotherapies Start Date: 2014-05-26 Last Updated: 2018-10-11 Number of Patients: 85 Recruitment Status: TERMINATED Condition: B-cell Lymphoma
NCTID: NCT03734198
Title: Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction Study Summary: Ibrutinib, a first-in-class Bruton Tyrosine kinase (BTK) inhibitor, has become an established treatment in relapsed/refractory chronic lymphocytic leukemia (CLL). However, despite a considerable improvement of Progression Free Survival (PFS) and Overall Survival (OS) in comparison with historical controls, the prognosis of patients with 17p deletion (del17p) remains a concern, as it is clearly much less favourable than that of patient without del17p. Again, TP53 mutations correlated to poorer prognostic in Relapsed/Refractory (R/R) CLL patients treated with ibrutinib (Brown JR et al,2018). Despite these therapeutic advances, the treatment of CLL with TP53 disruption thus remains a difficult issue that warrants evaluation of alternative treatment strategies, in particular the use of ibrutinib in combination with other agents. A body of evidence suggests that targeting the extracellular molecule CD38 might be an interesting option. CD38 is a transmembrane glycoprotein with multiple receptor and enzymatic functions. The interaction of CD38 with its ligand CD31 (also known as Platelet Endothelial Cell Adhesion Molecule (PECAM-1)) not only plays a role in the binding and the migration of leucocytes through the endothelial cells wall but also triggers the activation of intracellular pathways involved in the differentiation and activation of B cells. Previous results strongly suggest that CD38 favours the expansion of CLL clones not only directly by transducing a proliferation signal but also by directing them to anatomic sites where they find favourable conditions for proliferation and survival. Daratumumab is a first-in-class human IgG1ĸ monoclonal antibody (mAb) that binds CD38-expressing malignant cells with high affinity. Daratumumab induces tumor cell death through multiple mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) and induction of apoptosis (de Weers et al, 2011). Recent data show that daratumumab may also display an immunomodulatory effect through depletion of a subset of immunosuppressive CD38+ Tregs (Krejcik et al, 2016). Early-stage clinical trials found daratumumab to be safe and to display encouraging clinical activity as a single agent in relapsed/refractory multiple myeloma (MM) patients (Lockhorst et al 2016, Lonial et al, 2016). Overall response rate was 31%, with rapid (median 1 month) and durable responses in this heavily pretreated MM population. Interestingly, no patient discontinued the treatment because of drug-related adverse events. These results led to approval of daratumumab in relapsed/refractory MM in December 2015. The clinical efficacy of daratumumab along with its very favourable safety profile supports its investigation in other lymphoproliferative malignancies. In particular, the expression of CD38 in poor prognosis CLL and the key role of CD38 in CLL biology provide a basis for examining the potential of daratumumab in this disease. In preclinical studies, (Matas-Céspedes et al, 2016; Manna et al, 2017) Daratumumab efficiently kills CLL cell lines and patient-derived CLL cells by ADCC and ADCP in vitro. Daratumumab modulates CLL-T reg levels and increase cytotoxic effector T cells. Rationale for combining ibrutinib with daratumumab: These data suggest that combining ibrutinib with daratumumab might have a synergistic or additive effect. Both drugs inhibit B cell receptor (BCR) signalling via two different converging pathways, i.e. BTK and CD38/ZAP70/ERK (Deaglio et al, 2007). In vitro, Manna et al have shown that daratumumab is able to modulate BCR signaling. Interestingly, the ibrutinib /daratumumab combination significantly enhanced mitochondrial-mediated apoptosis bth in CD38 high and CD38 low CLL cells (Manna et al, 2017). Altogether, this provides a rationale for evaluating the safety and efficacy of the association of daratumumab with ibrutinib in high-risk relapsed/refractory patients for whom the standard-of-care using ibrutinib as a single agent has demonstrated limitations in terms of long-term disease control. Primary objective of the study: to determine the efficacy of a treatment combining daratumumab and ibrutinib in a poor risk population of relapsed CLL patients with TP53 dysfunction. Secondary objectives of the study : to determine the safety profile of daratumumab in combination with ibrutinib in CLL patients. Inclusion period: 24 months Treatment duration (ibrutinib + daratumumab): continuous, until disease progression or unacceptable toxicity. Follow-up period: will begin once the subject discontinues study treatment, during 2 years. Sponsor: French Innovative Leukemia Organisation Intervention: Ibrutinib Start Date: 2018-12-19 Last Updated: 2022-06-28 Number of Patients: 29 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed or Refractory Chronic Lymphocytic Leukemia
NCTID: NCT01748240
Title: Addition of Vorinostat to Azacitidine in Higher Risk MDS a Phase II add-on Study in Patients With Azacitidine Failure Study Summary: Azacytidine (AZA) is the current standard of care for frontline patient treated with high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this agents have shown more responses based on phase I/II data. In the present study, we will use the combination of these two drugs to try to create a synergetic effect and generate a response for patients who experienced treatment failure after AZA. All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days. Study Design Sponsor: Groupe Francophone des Myelodysplasies Intervention: Azacitidine and oral vorinostat Start Date: 2013-03 Last Updated: 2019-06-04 Number of Patients: 21 Recruitment Status: TERMINATED Condition: Myelodysplastic Syndrome
NCTID: NCT01582776
Title: Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma Study Summary: This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients. In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4). Sponsor: The Lymphoma Academic Research Organisation Intervention: Lenalidomide and GA101 Start Date: 2012-10-03 Last Updated: 2023-03-17 Number of Patients: 317 Recruitment Status: COMPLETED Condition: Follicular Lymphoma Patients (Phase IB)
NCTID: NCT02197676
Title: A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response Study Summary: Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response. Sponsor: Groupe Francophone des Myelodysplasies Intervention: SGI-110 administration Start Date: 2014-08-04 Last Updated: 2018-12-06 Number of Patients: 56 Recruitment Status: COMPLETED Condition: MDS
NCTID: NCT01608074
Title: Radical Fimbriectomy for Young BRCA Mutation Carriers Study Summary: Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion. Sponsor: Centre Oscar Lambret Intervention: Radical fimbriectomy Start Date: 2011-12 Last Updated: 2023-07-03 Number of Patients: 123 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: BRCA1 Mutation
NCTID: NCT00256776
Title: MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation Study Summary: This is an international study in adult patients diagnosed with multiple myeloma who have already received at least one autologous stem cell transplantation and who have responded but later progressed, or relapsed, at least one year after transplantation. Eligible patients will be randomly assigned to one of two treatments: either Velcade plus Thalidomide plus Dexamethasone or Thalidomide plus Dexamethasone. Thalidomide and Velcade are two new agents that have recently become available for the treatment of multiple myeloma, especially in relapsed patients. This study therefore aims to test the hypothesis that the combination treatment with Velcade plus Thalidomide plus Dexamethasone will result in a longer time to progression (measure of time after the disease is treated until it starts to get worse) than Thalidomide plus Dexamethasone alone. Sponsor: European Society for Blood and Marrow Transplantation Intervention: Velcade (Bortezomib) Start Date: 2005-07 Last Updated: 2021-10-18 Number of Patients: 269 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT04702581
Title: A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery Study Summary: Because of their prolonged survival, patients with 1p/19q-codeleted low-grade oligodendrogliomas treated with RT + PCV are at risk of neurocognitive deterioration. We make the hypothesis that withholding radiotherapy until tumor progression could reduce the risk of neurocognitive deterioration without impairing overall survival. Sponsor: Hospices Civils de Lyon Intervention: PCV chemotherapy Start Date: 2021-12-07 Last Updated: 2023-06-02 Number of Patients: 280 Recruitment Status: RECRUITING Condition: Oligodendroglioma
NCTID: NCT03624244
Title: Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS) Study Summary: The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS). Sponsor: Centre Leon Berard Intervention: Aromatase Inhibitors Start Date: 2019-01-23 Last Updated: 2023-09-01 Number of Patients: 40 Recruitment Status: RECRUITING Condition: Low Grade Endometrial Stromal Sarcoma
NCTID: NCT00083174
Title: Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer Study Summary: RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane. Sponsor: NCIC Clinical Trials Group Intervention: exemestane Start Date: 2004-12-03 Last Updated: 2023-08-25 Number of Patients: 4560 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00071799
Title: A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care Study Summary: The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled. See study AZA PH GL 2003 CL 001 E for information about the extension to this study. Sponsor: Celgene Intervention: Azacitidine Start Date: 2003-11-01 Last Updated: 2019-10-29 Number of Patients: 358 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT01045681
Title: Study of Bendamustine, Velcade and Dexamethasone in the Treatment of Elderly Patients With Multiple Myeloma Study Summary: The present trial is designed as a phase II study that aims at estimating the efficacy of the combination of bendamustine, bortezomib and dexamethasone in relapsed/refractory multiple myeloma (MM). The response rate, i.e. the rate of the patients achieving a Complete Response or Partial Response at cycle 4, divided by the total intent to treat patient number is chosen as primary efficacy endpoint. The estimation of the efficacy rate is to be based on an explorative pilot study, since immediate embarking on a large-scale comparative efficacy trial would not be acceptable from the point of view of resources. Moreover, this would induce ethical objections, as it does not seem to be justifiable to expose a large number of patients to an experimental approach without sufficient exploratory indications of an improved risk-benefit ratio. Sponsor: Intergroupe Francophone du Myelome Intervention: Bendamustine, Velcade and Dexamethasone Start Date: 2010-03-03 Last Updated: 2020-12-07 Number of Patients: 75 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT00104676
Title: Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors. Sponsor: UNICANCER Intervention: bleomycin sulfate Start Date: 2003-11-26 Last Updated: 2023-09-13 Number of Patients: 263 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Extragonadal Germ Cell Tumor
NCTID: NCT00135499
Title: R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma Study Summary: The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years. Sponsor: Lymphoma Study Association Intervention: Rituximab Start Date: 2001-10-16 Last Updated: 2018-08-23 Number of Patients: 138 Recruitment Status: TERMINATED Condition: Lymphoma, Large-Cell, Diffuse
NCTID: NCT02853370
Title: Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma Study Summary: Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered as a rare neoplasm accounting for about 2% of all non-Hodgkin’s lymphomas (NHL) and represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the disease pursues an aggressive course and most patients die of lymphoma progression within 3-4 years. Retrospective studies have indicated that purine analogous achieved very high response rates in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in combination with chemotherapy has been reported to be very effective in producing a rapid clearance of neoplastic cells. Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Bendamustine and Rituximab Start Date: 2012-07 Last Updated: 2023-02-01 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Marginal Zone B-cell Lymphoma
NCTID: NCT05840211
Title: Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy Study Summary: The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician’s choice (TPC) on progression-free survival (PFS). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2023-05-08 Last Updated: 2023-11-18 Number of Patients: 654 Recruitment Status: RECRUITING Condition: Locally Advanced or Unresectable Metastatic Breast Cancer
NCTID: NCT04220970
Title: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry Study Summary: Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant. Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP). This registry is opened in France and in Belgium Sponsor: The Lymphoma Academic Research Organisation Intervention: BIA-ALCL Start Date: 2017-06-07 Last Updated: 2023-09-26 Number of Patients: 150 Recruitment Status: RECRUITING Condition: Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)
NCTID: NCT02299999
Title: SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer Study Summary: Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2). Sponsor: UNICANCER Intervention: AZD2014 Start Date: 2014-04-07 Last Updated: 2023-02-06 Number of Patients: 1460 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT02861742
Title: Impact of Emotional Skills of Young Women and Their Partner on Adjustment to Cancer Study Summary: The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance. Sponsor: Centre Oscar Lambret Intervention: Delivery of questionnaires Start Date: 2016-07-25 Last Updated: 2019-06-26 Number of Patients: 800 Recruitment Status: UNKNOWN Condition: Aging
NCTID: NCT04109131
Title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours Study Summary: Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients’ outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies. Sponsor: Jules Bordet Institute Intervention: Samples collection: Plasma Start Date: 2020-07-01 Last Updated: 2023-03-28 Number of Patients: 600 Recruitment Status: RECRUITING Condition: CNS Metastases
NCTID: NCT05041842
Title: Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer Study Summary: The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment. Sponsor: UNICANCER Intervention: Tucatinib Start Date: 2021-12-17 Last Updated: 2023-09-22 Number of Patients: 55 Recruitment Status: RECRUITING Condition: Metastatic Breast Cancer With a Isolated Brain Progression
NCTID: NCT01313611
Title: BRIEF Bendamustine and Rituximab In Elderly Follicular Study Summary: The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden. This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks Sponsor: The Lymphoma Academic Research Organisation Intervention: Rituximab + bendamustine Start Date: 2011-02 Last Updated: 2018-03-07 Number of Patients: 62 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT01659099
Title: GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma Study Summary: This study is designed to investigate: * the interest of a new monoclonal antibody (GA101)versus rituximab * the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site’s choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required. Sponsor: The Lymphoma Academic Research Organisation Intervention: GA101 Start Date: 2012-09 Last Updated: 2018-03-07 Number of Patients: 671 Recruitment Status: TERMINATED Condition: Diffuse Large B Cell Lymphoma CD20 Positive
NCTID: NCT03515798
Title: Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer Study Summary: This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research. Sponsor: Institut Paoli-Calmettes Intervention: Pembrolizumab Injection Start Date: 2018-07-24 Last Updated: 2020-07-02 Number of Patients: 81 Recruitment Status: RECRUITING Condition: Inflammatory Breast Cancer
NCTID: NCT02022098
Title: Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial Study Summary: The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose. Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT. Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143. Sponsor: Debiopharm International SA Intervention: Cisplatin Start Date: 2013-10 Last Updated: 2022-06-23 Number of Patients: 144 Recruitment Status: COMPLETED Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT02934880
Title: Impact of Adapted Physical Activity on Cognitive Functions in Breast Cancer Study Summary: Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped. The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer. Sponsor: Centre Henri Becquerel Intervention: immediate APA program Start Date: 2016-10 Last Updated: 2018-07-11 Number of Patients: 152 Recruitment Status: UNKNOWN Condition: Breast Cancer
NCTID: NCT04384484
Title: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy. Sponsor: ADC Therapeutics S.A. Intervention: Loncastuximab Tesirine Start Date: 2020-09-16 Last Updated: 2023-09-21 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Relapsed Diffuse Large B-Cell Lymphoma
NCTID: NCT05768711
Title: Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR) Study Summary: Open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of Azacitidine combined with Venetoclax in patients with higher-risk chronic myelomonocytic leukemia Sponsor: Groupe Francophone des Myelodysplasies Intervention: Venetoclax Start Date: 2023-10-04 Last Updated: 2023-10-17 Number of Patients: 44 Recruitment Status: RECRUITING Condition: Chronic Myeloid Leukemia
NCTID: NCT00227669
Title: Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma Study Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma. PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma. Sponsor: UNICANCER Intervention: docetaxel Start Date: 2005-10 Last Updated: 2016-08-30 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Sarcoma
NCTID: NCT00911911
Title: Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy Study Summary: The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy. Sponsor: Centre Oscar Lambret Intervention: Blood sampling Start Date: 2007-01 Last Updated: 2012-07-31 Number of Patients: 66 Recruitment Status: COMPLETED Condition: Breast Cancer
NCTID: NCT00140569
Title: Randomized Study for Patients With Follicular Lymphoma Needing Treatment Study Summary: 2 parallel studies. * For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI * For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months Sponsor: Lymphoma Study Association Intervention: CHVP + interferon Start Date: 1994-01 Last Updated: 2005-09-01 Number of Patients: 400 Recruitment Status: COMPLETED Condition: Follicular Lymphoma
NCTID: NCT00169169
Title: Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma Study Summary: Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma. Sponsor: Lymphoma Study Association Intervention: ACVBP Start Date: 1999-10 Last Updated: 2005-09-15 Number of Patients: 430 Recruitment Status: TERMINATED Condition: CD20-Positive Large B-Cell Lymphoma
NCTID: NCT01262469
Title: Evaluating Lapatinib + Capecitabine in Patients Aged 70 and Over With HER2 Metastatic Breast Cancer. Study Summary: GERICO 09/0907 is a Phase II multicentric trial evaluating the toxicity and activity of the combination of lapatinib and capecitabine in locally advanced or metastatic breast cancer over expressing HER2 for patients aged ≥ 70 who have failed after one line of chemotherapy in combination with trastuzumab. Due to the minimal participation of older people in clinical trials, there is a lack of data to make evidence-based decisions regarding chemotherapy in this indication. The study is designed to investigate whether elderly patients with locally advanced or metastatic breast cancer over-expressing HER2 could take advantage of the combination lapatinib and capecitabine in term of clinical benefit, and with no adverse effects and no detrimental impact on functional status (part of geriatric assessment). The main objective is to assess clinical benefit (defined at 4 months as complete response, partial response or stable disease), safety and preserved geriatric independence (main objective is a “bi-criteria” or composite criteria). Sponsor: UNICANCER Intervention: lapatinib + capecitabine Start Date: 2009-12 Last Updated: 2014-12-16 Number of Patients: 4 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT01808599
Title: Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma Study Summary: Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma). Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Chlorambucil Start Date: 2013-12 Last Updated: 2023-05-18 Number of Patients: 112 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: MALT Lymphoma
NCTID: NCT00014599
Title: Paclitaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Cancer of the Vulva Study Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have locally advanced, metastatic, or recurrent cancer of the vulva. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: paclitaxel Start Date: 2001-02 Last Updated: 2012-09-24 Number of Patients: 31 Recruitment Status: COMPLETED Condition: Vulvar Cancer
NCTID: NCT00976911
Title: AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer Study Summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals. Sponsor: Hoffmann-La Roche Intervention: Bevacizumab Start Date: 2009-10-29 Last Updated: 2022-06-21 Number of Patients: 361 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT00673335
Title: Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation Study Summary: RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation. Sponsor: UNICANCER Intervention: letrozole Start Date: 2008-05 Last Updated: 2023-05-11 Number of Patients: 170 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: brca1 Mutation Carrier
NCTID: NCT04191135
Title: Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009) Study Summary: The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: # Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). # Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment is being discontinued. Participants who are receiving benefit from the study intervention may continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-12-19 Last Updated: 2023-06-23 Number of Patients: 462 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT03079011
Title: PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection Study Summary: This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population. Sponsor: UNICANCER Intervention: Palbociclib 125mg Start Date: 2017-03-22 Last Updated: 2023-09-22 Number of Patients: 1017 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Breast Cancer
NCTID: NCT00667069
Title: Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer Study Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer. Sponsor: UNICANCER Intervention: triptorelin Start Date: 2008-04-07 Last Updated: 2023-04-14 Number of Patients: 424 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Prostate Cancer
NCTID: NCT02320435
Title: A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial Study Summary: This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator’s opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Pertuzumab Start Date: 2015-02-02 Last Updated: 2023-11-13 Number of Patients: 154 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Solid Tumor
