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
