Trials (Fondazione I.R.C.C.S. Policlinico San Matteo)
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NCTID: NCT05210790
Title: A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera Study Summary: The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV. Sponsor: Protagonist Therapeutics, Inc. Intervention: Placebo Start Date: 2022-04-01 Last Updated: 2023-11-09 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Polycythemia Vera
NCTID: NCT04034056
Title: Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN) Study Summary: To evaluate the effectiveness and safety of obinutuzumab in clinical routine in 1L FL measured by the % of relapse within 24 months from start of therapy. Sponsor: Hoffmann-La Roche Intervention: Obinutuzumab Start Date: 2019-09-02 Last Updated: 2023-10-04 Number of Patients: 299 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT02165397
Title: Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Study Summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström’s macroglobulinemia (WM). Sponsor: Pharmacyclics LLC. Intervention: Ibrutinib Start Date: 2014-07-07 Last Updated: 2021-03-03 Number of Patients: 181 Recruitment Status: COMPLETED Condition: Waldenström’s Macroglobulinemia
NCTID: NCT04987203
Title: Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Study Summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib Start Date: 2021-09-09 Last Updated: 2023-11-28 Number of Patients: 326 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT00916890
Title: Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain Study Summary: Aim of this project is to customize the choice of the strong opioid in the treatment of cancer chronic pain through the identification of patient clinical history and pain characteristics, moreover in the analysis the investigators will also correlate the clinical efficacy and safety of opioid treatment with pharmacokinetic and pharmacogenetic patterns in order to identify variables able to predict the efficacy of the treatment or the patient susceptibility towards a specific treatment. Furthermore with this study the investigators want to identify the pharmacogenomic characterization responsible for pharmacokinetic variability in the conversion between morphine and other opioids, in order to validate the currently available conversion tables from a pharmacokinetic viewpoint, estimating the influence of the most common genetic polymorphisms, and if this characterization could be useful and cost-effective. This study will also focus on the specific clinical-pharmacological response in the elderly and between male and female and on the interactions between opioids and those anticonvulsant and antidepressant drugs routinely used in the pain therapy (study of pharmacovigilance). Sponsor: IRCCS Policlinico S. Matteo Intervention: Morphine Start Date: 2009-02 Last Updated: 2014-01-09 Number of Patients: 320 Recruitment Status: SUSPENDED Condition: Chronic Pain
NCTID: NCT04210115
Title: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Study Summary: The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab Start Date: 2020-02-28 Last Updated: 2023-11-27 Number of Patients: 700 Recruitment Status: RECRUITING Condition: Esophageal Squamous Cell Carcinoma (ESCC)
NCTID: NCT02828150
Title: Integrative Parenteral Nutrition in Cancer Patients Study Summary: Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients. International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients. Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools. Sponsor: IRCCS Policlinico S. Matteo Intervention: Parenteral nutrition Start Date: 2016-07 Last Updated: 2017-12-04 Number of Patients: 131 Recruitment Status: COMPLETED Condition: Neoplasms
NCTID: NCT02979522
Title: A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma Study Summary: The purpose of this study is to assess the safety, tolerability, and anti-tumor activity, as well as confirm the recommended dose of brentuximab vedotin (ADCETRIS) in combination with a multiagent chemotherapy regimen, doxorubicin (Adriamycin), vinblastine, and dacarbazine, in pediatric participants with advanced stage newly diagnosed classical CD30+ Hodgkin Lymphoma (HL). Sponsor: Takeda Intervention: Brentuximab vedotin Start Date: 2017-09-06 Last Updated: 2022-06-24 Number of Patients: 59 Recruitment Status: COMPLETED Condition: Hodgkin Disease
NCTID: NCT04109066
Title: Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer Study Summary: A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer. Sponsor: Bristol-Myers Squibb Intervention: nivolumab Start Date: 2019-11-20 Last Updated: 2023-11-18 Number of Patients: 521 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04460807
Title: Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer Study Summary: In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS). Sponsor: Ente Ospedaliero Ospedali Galliera Intervention: Exemestane Start Date: 2020-02-13 Last Updated: 2020-07-08 Number of Patients: 468 Recruitment Status: UNKNOWN Condition: Ovarian Cancer
NCTID: NCT01383707
Title: A Study of Bevacizumab and Modified FOLFOX-6 (mFOLFOX-6) in Participants With Metastatic Colorectal Cancer Study Summary: The multicenter, open-label, single-arm, non-randomized, two-stage Simon’s design, phase II study (The CLMO-001 Trial) will evaluate the efficacy and safety of bevacizumab in combination with mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil <math display="block">5-FU</math> and oxaliplatin) in participants with colorectal cancer and liver metastases. Participants will receive combination therapy of bevacizumab 5 milligrams per kilogram (mg/kg) intravenous (IV) dose and mFOLFOX-6 every 2 weeks during Cycles 1-5 and Cycles 7-12. Participants will receive mFOLFOX-6 alone (without bevacizumab) on Cycle 6. In between Cycle 6 and 7, participants will undergo liver surgery if operable. Thereafter participants will receive bevacizumab (5 mg/kg IV every 2 weeks) alone for 52 weeks (26 cycles) after the end of the post-operative phase (maintenance therapy). At the end of the preoperative treatment phase (Cycles 1-6), participants showing different alternative conditions admitted by the protocol will undergo different management (alternative study designs 1 to 3). Sponsor: Hoffmann-La Roche Intervention: 5-Fluorouracil (5-FU) Start Date: 2011-08-12 Last Updated: 2017-06-14 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Colorectal Cancer
NCTID: NCT04404283
Title: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL Study Summary: Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is “blinded,” participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL. Sponsor: Seagen Inc. Intervention: Brentuximab vedotin Start Date: 2020-08-20 Last Updated: 2023-11-29 Number of Patients: 225 Recruitment Status: RECRUITING Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT01523847
Title: A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin’s Lymphoma (HL) Study Summary: The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: MBVD (Myocet+BVD) Start Date: 2010-11 Last Updated: 2016-08-04 Number of Patients: 50 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT05929222
Title: Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi Study Summary: Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinotuzumab. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Radiotherapy Start Date: 2024-01 Last Updated: 2023-09-08 Number of Patients: 190 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT03154047
Title: Study in Subjects With Light Chain (AL) Amyloidosis Study Summary: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201. Sponsor: Prothena Biosciences Ltd. Intervention: NEOD001 Start Date: 2017-06-14 Last Updated: 2019-03-26 Number of Patients: 80 Recruitment Status: TERMINATED Condition: AL Amyloidosis
NCTID: NCT04663347
Title: Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) Study Summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL). Sponsor: Genmab Intervention: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone Start Date: 2020-11-03 Last Updated: 2023-08-08 Number of Patients: 662 Recruitment Status: RECRUITING Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT04910685
Title: (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis Study Summary: This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or Part 2 will roll over onto Part 3 to receive treatment with BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM. Sponsor: Blueprint Medicines Corporation Intervention: BLU-263 Start Date: 2021-11-30 Last Updated: 2023-10-23 Number of Patients: 443 Recruitment Status: RECRUITING Condition: Indolent Systemic Mastocytosis
NCTID: NCT03860883
Title: Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma Study Summary: Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life. Sponsor: Melanoma and Skin Cancer Trials Limited Intervention: Wide Local Excision = 1cm Margin Start Date: 2019-12-17 Last Updated: 2023-10-19 Number of Patients: 2998 Recruitment Status: RECRUITING Condition: Cutaneous Melanoma, Stage II
NCTID: NCT01662050
Title: Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL Study Summary: A phase 2 study of standard R-BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara-c 800 mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine + ara-c combination had very good clinical activity, but a quite relevant hematological toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano Conference, Poster 236). Objectives: The primary objective is to determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age-adjusted Rituximab-Bendamustine-Cytarabine (RBAC500) regimen at the end of treatment in older untreated patients with MCL. The secondary objectives are to determine: * The rate of molecular response (characterized by labs of the FIL) * The progression-free survival (PFS) * The overall survival (OS) * The duration of responses (DOR) * The rate of patients that complete the expected treatment schedule (6 courses) * The rate of patients that are subject to dose reductions or delays Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Rituximab, Bendamustine, Cytarabine. Start Date: 2012-03-20 Last Updated: 2022-08-09 Number of Patients: 57 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT02112175
Title: Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM Study Summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma. After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator’s discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2014-04-30 Last Updated: 2021-04-14 Number of Patients: 46 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT03694522
Title: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer Study Summary: The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer. Sponsor: Five Prime Therapeutics, Inc. Intervention: Bemarituzumab Start Date: 2018-09-14 Last Updated: 2022-12-16 Number of Patients: 155 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT05748171
Title: A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL Study Summary: This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization. Sponsor: Pfizer Intervention: Inotuzumab ozogamicin Start Date: 2023-05-17 Last Updated: 2023-11-14 Number of Patients: 100 Recruitment Status: RECRUITING Condition: ACUTE LYMPHOBLASTIC LEUKEMIA
NCTID: NCT04582539
Title: To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma Study Summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. Sponsor: Incyte Corporation Intervention: INCB000928 Start Date: 2021-08-19 Last Updated: 2023-10-23 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT02999854
Title: Safety and Efficacy of ATIR101 as Adjunctive Treatment to Blood Stem Cell Transplantation From a Haploidentical Family Donor Compared to Post-transplant Cyclophosphamide in Patients With Blood Cancer Study Summary: The primary objective of this study is to compare safety and efficacy of a haploidentical T-cell depleted HSCT and adjunctive treatment with ATIR101 versus a haploidentical T cell replete HSCT with post-transplant administration of high dose cyclophosphamide (PTCy) in patients with a hematologic malignancy. An additional objective of the study is to compare the effect of the two treatments on quality of life. Sponsor: Kiadis Pharma Intervention: ATIR101 Start Date: 2017-11-29 Last Updated: 2022-05-24 Number of Patients: 63 Recruitment Status: TERMINATED Condition: Acute Myeloid Leukemia
NCTID: NCT03394365
Title: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy Study Summary: The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab. Sponsor: Atara Biotherapeutics Intervention: tabelecleucel Start Date: 2017-12-29 Last Updated: 2022-06-24 Number of Patients: 66 Recruitment Status: RECRUITING Condition: Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
NCTID: NCT03194542
Title: A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence Study Summary: This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period. Sponsor: Celgene Intervention: Luspatercept Start Date: 2017-11-15 Last Updated: 2023-08-24 Number of Patients: 95 Recruitment Status: COMPLETED Condition: Primary Myelofibrosis
NCTID: NCT03063762
Title: Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma (RCC) Study Summary: This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-03-20 Last Updated: 2023-02-17 Number of Patients: 69 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT04666038
Title: Study of LOXO-305 Versus Investigator’s Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Study Summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: LOXO-305 Start Date: 2021-03-09 Last Updated: 2023-11-01 Number of Patients: 250 Recruitment Status: RECRUITING Condition: Chronic Lymphocytic Leukemia
NCTID: NCT03320642
Title: GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease Study Summary: The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD). Sponsor: Incyte Corporation Intervention: Itacitinib Start Date: 2018-02-27 Last Updated: 2022-05-02 Number of Patients: 84 Recruitment Status: TERMINATED Condition: Hematologic Malignancies
NCTID: NCT04728893
Title: Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003) Study Summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter’s transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström’s macroglobulinemia (WM). Sponsor: Merck Sharp & Dohme LLC Intervention: Nemtabrutinib Start Date: 2021-04-05 Last Updated: 2023-11-24 Number of Patients: 450 Recruitment Status: RECRUITING Condition: Hematologic Malignancies
NCTID: NCT02627963
Title: A Study to Compare Tivozanib Hydrochloride to Sorafenib in Participants With Refractory Advanced Renal Cell Carcinoma (RCC) Study Summary: This is a Phase 3, open-label, randomized, controlled, multi-national, multi-center, parallel-arm study comparing tivozanib to sorafenib in participants with refractory advanced renal cell carcinoma (RCC). Participants will be randomized (1:1) to treatment with tivozanib or sorafenib. Participants will be stratified by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category (favorable; intermediate; poor) and prior therapy (two prior vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKI); a prior checkpoint inhibitor <math display="block">programmed cell death -1 protein (PD-1) or PD-1 ligand (PD1-L) inhibitor</math> plus a prior VEGFR TKI; a prior VEGFR TKI plus any other systemic agent). All participants will be evaluated for progression free survival, overall survival, objective response rate, and the duration of response as well as safety and tolerability. Pharmacokinetic (PK) analyses are also included in study. Sponsor: AVEO Pharmaceuticals, Inc. Intervention: Tivozanib hydrochloride Start Date: 2016-05-24 Last Updated: 2023-07-18 Number of Patients: 350 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT02184416
Title: Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting Study Summary: This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months. Sponsor: Pfizer Intervention: observational Start Date: 2014-10-31 Last Updated: 2023-05-01 Number of Patients: 573 Recruitment Status: COMPLETED Condition: Metastatic Renal Cell Carcinoma (mRCC)
NCTID: NCT02594163
Title: Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma Study Summary: This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT). Sponsor: Seagen Inc. Intervention: Brentuximab Vedotin Start Date: 2015-10 Last Updated: 2018-10-16 Number of Patients: 25 Recruitment Status: TERMINATED Condition: Diffuse Large B-cell Lymphoma Refractory
NCTID: NCT04848493
Title: National Project on Vaccines, COVID-19 and Frail Patients Study Summary: This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies. Sponsor: Azienda Unità Sanitaria Locale Reggio Emilia Intervention: COVID-19 vaccines Start Date: 2021-04-19 Last Updated: 2021-04-22 Number of Patients: 1300 Recruitment Status: UNKNOWN Condition: COVID-19
NCTID: NCT00844649
Title: Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas Study Summary: Phase III Metastatic Pancreatic Cancer Sponsor: Celgene Intervention: Albumin-bound paclitaxel (ABI-007) Start Date: 2009-03-01 Last Updated: 2019-11-25 Number of Patients: 861 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Cancer
NCTID: NCT01761968
Title: Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms Study Summary: This is a multicenter, open label, long-term study testing the long-term safety, tolerability and efficacy of givinostat in patients with Polycythemia Vera, Essential Thrombocythemia, primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis following core protocols in chronic myeloproliferative neoplasms and/or patient-named compassionate use program (if regulated/allowed by the local regulations, e.g. for Italy D.M. 8/5/2003 “Uso terapeutico di medicinale sottoposto a sperimentazione clinica” published on G.U. n. 173 of 28 July 2003, and the following amendments). Patients will continue at their last tolerable dose and treatment schedule of givinostat monotherapy. If patients previously received givinostat in combination with other drugs during a core protocol or a compassionate use program (if regulated/allowed by the local regulations, e.g. for Italy D.M. 8/5/2003 “Uso terapeutico di medicinale sottoposto a sperimentazione clinica” published on G.U. n. 173 of 28 July 2003, and the following amendments), they will be treated at the last tolerable dose of the combination. Assessment of safety and efficacy will be performed at each quarterly visit and each visit will also include laboratory tests and ECG examination. During the visits the clinical benefit will be assessed by Investigator according to the revised European LeukemiaNet response criteria (for PV and ET) and EUMNET response criteria (for MF). The dose of Givinostat will be modified for protocol specified toxicities. The treatment may continue up to Marketing Authorization of givinostat, currently planned in the next 5 years (note: only for Germany, this long-term study is initially limited up to 2 years of treatment). Patients may discontinue study treatment at any time and remain on study therapy as long as they derive clinical benefit. Safety will be monitored at each visit throughout the entire duration of the study. In case the approved label will not cover the whole study population, givinostat will be provided by the Sponsor to those patients not fulfilling the criteria for the approved label of the drug that are still deriving benefit from givinostat at the time of its commercial availability. Sponsor: Italfarmaco Intervention: givinostat Start Date: 2013-03 Last Updated: 2021-06-15 Number of Patients: 90 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Myeloproliferative Neoplasms
NCTID: NCT03235245
Title: Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib Study Summary: This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Nivolumab + Ipilimumab Start Date: 2018-10-30 Last Updated: 2023-11-03 Number of Patients: 271 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Unresectable Stage III Melanoma
NCTID: NCT04192916
Title: Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms Study Summary: Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events). While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known. The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of: * cardioembolic stroke in patients with MPN with AF * recurrent thrombosis in patients with MPN with VTE * major bleeding in all patients with MPN. The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding. Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: DOACs Start Date: 2019-09-01 Last Updated: 2021-02-21 Number of Patients: 442 Recruitment Status: COMPLETED Condition: Myeloproliferative Neoplasm
NCTID: NCT01681563
Title: Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia Study Summary: This is a phase II multicenter, non-comparative, open label study in older previously untreated Chronic Lymphocytic Leukaemia patients, requiring therapy, aimed at defining the efficacy profile (ORR, CRR and TTP) of pentostatin and cyclophosphamide given in combination with Ofatumumab (PCO). Sponsor: Niguarda Hospital Intervention: Pentostatin Start Date: 2011-09 Last Updated: 2016-12-28 Number of Patients: 47 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT01642563
Title: Italian Platelet Technology Assessment Study Study Summary: Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately. Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets. Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization Patients will be evaluated for 4 weeks after randomization. Sponsor: Centro Nazionale Sangue Intervention: Platelet transfusion Start Date: 2010-10 Last Updated: 2015-07-28 Number of Patients: 456 Recruitment Status: TERMINATED Condition: Leukemia
NCTID: NCT03277105
Title: A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma Study Summary: The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough). Sponsor: Janssen Research & Development, LLC Intervention: Dara SC Start Date: 2017-10-27 Last Updated: 2023-10-11 Number of Patients: 522 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT04680052
Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. Study Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL. Sponsor: Incyte Corporation Intervention: tafasitamab Start Date: 2021-04-15 Last Updated: 2023-08-18 Number of Patients: 654 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT00430352
Title: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin’s Lymphoma. Study Summary: This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin’s lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals. Sponsor: Hoffmann-La Roche Intervention: rituximab [MabThera/Rituxan] Start Date: 2006-09-04 Last Updated: 2017-08-14 Number of Patients: 545 Recruitment Status: COMPLETED Condition: Non-Hodgkin’s Lymphoma
NCTID: NCT04035226
Title: A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment Study Summary: The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM). Sponsor: Janssen-Cilag Ltd. Intervention: No intervention Start Date: 2019-08-02 Last Updated: 2022-12-21 Number of Patients: 254 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT01876927
Title: Pre-Operative Or Peri-Operative Dox Regimen In Patients With Locally Advanced Resectable Gastric Cancer Study Summary: Study design: Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up Population: Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach. Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2) Treatment Plan: Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery. After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles. DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks Cycles repeated every 3 weeks Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1). Duration of Study: Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Intervention: DOX 4 cycles - Surgery Start Date: 2010-09 Last Updated: 2017-07-21 Number of Patients: 90 Recruitment Status: COMPLETED Condition: Gastric Cancer
NCTID: NCT03390504
Title: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations Study Summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-<math display="block">L</math>1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2). Sponsor: Janssen Research & Development, LLC Intervention: Erdafitinib Start Date: 2018-03-23 Last Updated: 2023-11-13 Number of Patients: 629 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Urothelial Cancer
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: NCT00774826
Title: Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma Study Summary: The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms: R-CVP vs R-CHOP vs R-FM. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-CVP Start Date: 2005-12 Last Updated: 2011-02-15 Number of Patients: 534 Recruitment Status: UNKNOWN Condition: Follicular Lymphoma
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: NCT03055026
Title: Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer. Study Summary: Rivaroxaban or placebo for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer: a randomized, double blind, placebo-controlled study. Sponsor: Fadoi Foundation, Italy Intervention: Rivaroxaban Start Date: 2017-05-03 Last Updated: 2022-03-11 Number of Patients: 582 Recruitment Status: COMPLETED Condition: Prevention of Venous Thromboembolism
NCTID: NCT02065726
Title: Whey Protein Supplementation in Cancer Patients Study Summary: Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited. Sponsor: IRCCS Policlinico S. Matteo Intervention: Whey protein Start Date: 2014-02-25 Last Updated: 2018-06-08 Number of Patients: 166 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT05462717
Title: Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Study Summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose. Sponsor: Revolution Medicines, Inc. Intervention: RMC-6291 Start Date: 2022-09-19 Last Updated: 2023-10-18 Number of Patients: 117 Recruitment Status: RECRUITING Condition: Non-Small Cell Lung Cancer (NSCLC)
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: NCT03455504
Title: Venetoclax Add in Combination With Fludarabine, Cyratabine and Idarubicine in Induction for Acute Myelid Leukemia Study Summary: This study will test the effectiveness and safety of Venetoclax in combination with standard induction regimen for patients with acute leukemia and poor prognosis. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Venetoclax Start Date: 2018-10-26 Last Updated: 2023-01-10 Number of Patients: 124 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT02223208
Title: Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas Study Summary: This is a multicenter study that includes two phases: # A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study. # A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Ro-CHOEP-21 (PHASE I) Start Date: 2014-09 Last Updated: 2023-09-13 Number of Patients: 89 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Peripheral T-cell Lymphomas (PTCL)
NCTID: NCT05455320
Title: A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment Study Summary: The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Sponsor: Janssen Research & Development, LLC Intervention: Talquetamab Start Date: 2022-10-13 Last Updated: 2023-11-08 Number of Patients: 810 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT02724020
Title: MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Study Summary: The purpose of this study is to evaluate the efficacy and safety of single-agent MLN0128 and the combination of MLN0128 + MLN1117 compared with everolimus in the treatment of participants with metastatic clear-cell renal cell carcinoma (mccRCC) that have progressed on vascular endothelial growth factor (VEGF)-targeted therapy. Sponsor: Millennium Pharmaceuticals, Inc. Intervention: Everolimus Start Date: 2016-06-30 Last Updated: 2021-11-19 Number of Patients: 96 Recruitment Status: COMPLETED Condition: Clear-cell Metastatic Renal Cell Carcinoma
NCTID: NCT03976375
Title: Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) Study Summary: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2019-06-26 Last Updated: 2023-10-02 Number of Patients: 422 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Metastatic Non-Small Cell Lung Cancer
NCTID: NCT04194775
Title: A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma Study Summary: This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product of and lenvatinib is selected as the basic treatment for HCC. Sponsor: CStone Pharmaceuticals Intervention: Nofazinlimab (CS1003)+Lenvatinib Start Date: 2019-12-13 Last Updated: 2023-07-10 Number of Patients: 534 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hepatocellular Carcinoma
NCTID: NCT02099175
Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Operable Patients Study Summary: Sinonasal tumors are rare diseases, so no standard treatment for such aggressive tumors has been reported, given rarity, absence of prospective study and heterogeneity of histologies and stages of diseases. This study proposes innovative integration of multiple modality of treatment depending by histology, molecular profile and response to induction CT. Moreover, such strategies allows the use of latest technology with greater biological effectiveness and reduction of toxicities. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Cisplatin Start Date: 2013-11 Last Updated: 2023-03-13 Number of Patients: 41 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Sinonasal Tumors
NCTID: NCT01981850
Title: A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Study Summary: RO7490677 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF), a disease in which the bone marrow, which is the organ in the body that makes blood cells, is replaced by fibrosis, or excess scar tissue. The purpose of this study is to gather information on whether RO7490677 has an effect on the MF disease, whether it is safe in patients with MF, and how well it is tolerated. Sponsor: Hoffmann-La Roche Intervention: RO7490677 Start Date: 2013-10-01 Last Updated: 2022-01-05 Number of Patients: 125 Recruitment Status: COMPLETED Condition: Primary Myelofibrosis
NCTID: NCT02436668
Title: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE) Study Summary: This is a phase 3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma. Sponsor: Pharmacyclics LLC. Intervention: Ibrutinib Start Date: 2015-05 Last Updated: 2020-12-30 Number of Patients: 430 Recruitment Status: COMPLETED Condition: Metastatic Pancreatic Adenocarcinoma
NCTID: NCT03949907
Title: Early IntraVenous Administration of Nutritional Support Study Summary: The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy. Sponsor: IRCCS Policlinico S. Matteo Intervention: Nutritional counseling alone Start Date: 2020-04-14 Last Updated: 2022-05-05 Number of Patients: 192 Recruitment Status: RECRUITING Condition: Cancer of Stomach
NCTID: NCT05587296
Title: A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer Study Summary: Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment. To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment. The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant. All participants will continue taking the anti-cancer therapy they have been using when entering the study. Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks. Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152. During the study, the participants will: * record information about their hot flashes * answer questions about their quality of life and other symptoms. The doctors and their study team will: * check the participants health and vital signs * take blood and urine samples * examine heart health using electrocardiogram (ECG) * examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs * make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable) * check the health of the participant’s cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable) * take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis. * ask the participants questions about what medicines they are taking and if they are having adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants’ health. Sponsor: Bayer Intervention: Elinzanetant (BAY3427080) Start Date: 2022-10-14 Last Updated: 2023-11-13 Number of Patients: 405 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
NCTID: NCT04875195
Title: A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68) Study Summary: The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2021-06-07 Last Updated: 2023-11-14 Number of Patients: 60 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Hodgkin’s Lymphoma
NCTID: NCT04266795
Title: A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy Study Summary: The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time. Sponsor: Takeda Intervention: Pevonedistat Start Date: 2020-10-13 Last Updated: 2023-09-28 Number of Patients: 164 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Myeloid Leukemia (AML)
NCTID: NCT05229614
Title: Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease Study Summary: Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response. Considering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care. Sponsor: CNAO National Center of Oncological Hadrontherapy Intervention: Carbon Ion Therapy Start Date: 2022-07-26 Last Updated: 2023-05-25 Number of Patients: 27 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT05199337
Title: Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis Study Summary: This is a single arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis. Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. Intervention: ZN-d5 Start Date: 2021-11-30 Last Updated: 2023-07-10 Number of Patients: 135 Recruitment Status: RECRUITING Condition: Amyloidosis
NCTID: NCT02055833
Title: Intensive Nutritional Counseling in Head-neck Cancer Patients Undergoing Radiotherapy Study Summary: In head-neck cancer patients undergoing radiotherapy (RT) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. The international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. Previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ONS). Accordingly, although current guidelines recommend as grade A the use of ONS associated with dietary counseling for head-neck cancer patients undergoing RT, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials. Sponsor: IRCCS Policlinico S. Matteo Intervention: Intensive nutritional counseling Start Date: 2013-09 Last Updated: 2016-08-30 Number of Patients: 159 Recruitment Status: COMPLETED Condition: Head-neck Cancer
NCTID: NCT03215030
Title: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma Study Summary: The main aims of this 3-part study are as follows: Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found. Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants. Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa. Participants will receive modakafusp alfa at one of two doses which will be given through a vein. Sponsor: Takeda Intervention: Modakafusp alfa Start Date: 2017-10-04 Last Updated: 2023-11-27 Number of Patients: 336 Recruitment Status: RECRUITING Condition: Multiple Myeloma
NCTID: NCT02864030
Title: PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment Study Summary: On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease. As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted. Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated. Sponsor: Oncologia Medica dell’Ospedale Fatebenefratelli Intervention: ERIBULIN MESYLATE Start Date: 2014-05 Last Updated: 2021-03-04 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Metastatic Breast Cancer
NCTID: NCT04053231
Title: Hepatocarcinoma Recurrence on the Liver Study - Part2 Study Summary: Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies. Sponsor: University of Milano Bicocca Intervention: liver resection Start Date: 2019-09 Last Updated: 2019-08-12 Number of Patients: 3000 Recruitment Status: NOT_YET_RECRUITING Condition: Liver Cancer
NCTID: NCT04709731
Title: Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid Leukemia Study Summary: This study will address the therapeutic activity and the safety/biological profile of Ponatinib when used as third line therapy of Chronic Myeloid Leukemia in Chronic Phase after the only two TKIs known for their cardiovascular safety, i.e. Imatinib and Bosutinib. Sponsor: Associazione Italiana Pazienti Leucemia Mieloide Cronica Intervention: Ponatinib 15mg QD Start Date: 2021-02-01 Last Updated: 2021-02-03 Number of Patients: 50 Recruitment Status: NOT_YET_RECRUITING Condition: Chronic Myeloid Leukemia (CML)
NCTID: NCT02420821
Title: A Study of Atezolizumab in Combination With Bevacizumab Versus Sunitinib in Participants With Untreated Advanced Renal Cell Carcinoma (RCC) Study Summary: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic RCC who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody Start Date: 2015-05-20 Last Updated: 2023-01-30 Number of Patients: 915 Recruitment Status: COMPLETED Condition: Renal Cell Carcinoma
NCTID: NCT01728155
Title: European Low and Intermediate Risk Neuroblastoma Protocol
Study Summary: The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with “non high risk” neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. # LOW RISK STUDY The Low Risk Study is proposed in order to:
minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.
- INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to: * reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; * increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; * improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; * maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation
Sponsor: Instituto de Investigacion Sanitaria La Fe Intervention: chemotherapy Start Date: 2011-01-01 Last Updated: 2023-09-08 Number of Patients: 685 Recruitment Status: COMPLETED Condition: LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
NCTID: NCT01566721
Title: A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Study Summary: This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B). Sponsor: Hoffmann-La Roche Intervention: Herceptin Start Date: 2012-05-17 Last Updated: 2021-04-27 Number of Patients: 2577 Recruitment Status: COMPLETED Condition: Breast Neoplasms
NCTID: NCT05128630
Title: Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC. Study Summary: Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT. Sponsor: IRCCS Policlinico S. Matteo Intervention: Durvalumab Start Date: 2021-10-28 Last Updated: 2023-09-28 Number of Patients: 45 Recruitment Status: RECRUITING Condition: NSCLC, Stage III
NCTID: NCT03697512
Title: MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas Study Summary: Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: Ibrutinib Start Date: 2019-09-27 Last Updated: 2023-05-10 Number of Patients: 175 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Marginal Zone Lymphoma
NCTID: NCT05222555
Title: Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients Study Summary: This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry. Sponsor: MorphoSys AG Intervention: Tafasitamab Start Date: 2022-07-19 Last Updated: 2023-11-24 Number of Patients: 51 Recruitment Status: RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT02709512
Title: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Study Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die. Sponsor: Polaris Group Intervention: ADI-PEG 20 plus Pem Platinum Start Date: 2017-08-01 Last Updated: 2023-10-04 Number of Patients: 249 Recruitment Status: COMPLETED Condition: Mesothelioma
NCTID: NCT00786851
Title: Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL) Study Summary: This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Lenalidomide and Dexametasone Start Date: 2008-07 Last Updated: 2016-08-17 Number of Patients: 33 Recruitment Status: COMPLETED Condition: MANTLE CELL LYMPHOMA
NCTID: NCT02371148
Title: Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study Summary: This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom’s Macroglobulinemia. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Bortezomib-Rituximab-Bendamustine Start Date: 2014-06 Last Updated: 2020-12-02 Number of Patients: 38 Recruitment Status: COMPLETED Condition: Waldenstrom’s Macroglobulinemia
NCTID: NCT04793919
Title: Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia Study Summary: The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age. Sponsor: Associazione Italiana Ematologia Oncologia Pediatrica Intervention: Mylotarg Start Date: 2019-10-09 Last Updated: 2022-08-10 Number of Patients: 89 Recruitment Status: RECRUITING Condition: Acute Promyelocytic Leukemia
NCTID: NCT05593614
Title: Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) Study Summary: The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients. Sponsor: AlgoTherapeutix Intervention: ATX01 10% Start Date: 2023-02-28 Last Updated: 2023-10-19 Number of Patients: 240 Recruitment Status: RECRUITING Condition: Chemotherapy-induced Peripheral Neuropathy
NCTID: NCT04074330
Title: A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma Study Summary: This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts. The main aims of the study are: * To check for side effects from treatment with TAK-981 given with rituximab. * To check how much TAK-981 participants can tolerate. * To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment. Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons. Sponsor: Takeda Intervention: TAK-981 Start Date: 2019-10-15 Last Updated: 2023-05-11 Number of Patients: 39 Recruitment Status: COMPLETED Condition: Lymphoma, Non-Hodgkin
NCTID: NCT03659448
Title: Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer Study Summary: The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard “white light” visualization during surgical resections of colorectal cancer. Sponsor: Surgimab Intervention: SGM-101 Start Date: 2019-06-17 Last Updated: 2022-05-05 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms
NCTID: NCT00458848
Title: Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia Study Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: asparaginase Start Date: 2004-10 Last Updated: 2019-02-15 Number of Patients: 470 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT03173248
Title: Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Study Summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study. Sponsor: Institut de Recherches Internationales Servier Intervention: AG-120 Start Date: 2017-06-26 Last Updated: 2023-07-12 Number of Patients: 146 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Newly Diagnosed Acute Myeloid Leukemia (AML)
NCTID: NCT03270748
Title: Post Transplant High-Dose Cy as GvHD Prophylaxis in 1 HLA Mismatched Unrelated HSCT for Myeloid Malignancies Study Summary: The experimental treatment consists in the application of a therapeutic strategy with post Transplant High-Dose Cyclophosphamide as GvHD Prophylaxis in Patients Receiving 1-Antigen/Allele HLA Mismatched (7/8 matched) Unrelated Hemopoietic Stem Cell Transplantation for Myeloid Malignancies. Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: GvHD prophylaxis Start Date: 2020-01-15 Last Updated: 2023-03-10 Number of Patients: 78 Recruitment Status: COMPLETED Condition: Myeloid Malignancies
NCTID: NCT05967689
Title: A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation. Study Summary: The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other mutations. Sponsor: Taiho Oncology, Inc. Intervention: TAS6417 Start Date: 2023-07-27 Last Updated: 2023-11-29 Number of Patients: 160 Recruitment Status: RECRUITING Condition: Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
NCTID: NCT02733042
Title: A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia Study Summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL). Sponsor: Celgene Intervention: Durvalumab Start Date: 2016-05-11 Last Updated: 2023-11-18 Number of Patients: 106 Recruitment Status: COMPLETED Condition: Lymphoma
NCTID: NCT01929265
Title: A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin’s Lymphoma Study Summary: This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Bendamustine Start Date: 2011-01 Last Updated: 2017-10-13 Number of Patients: 73 Recruitment Status: COMPLETED Condition: Indolent Non-follicular
NCTID: NCT02262221
Title: Health and Economic Outcomes of Two Different Follow up Strategies in Effectively Cured Advanced Head and Neck Cancer Study Summary: Randomized, multicenter trial to evaluate the cost-effectiveness of 2 different follows up programs in head and neck cancer survivors. Patients in complete remission at month 6 (+/- 1 month) after curative treatment will be randomized in two arms according to 2 different follow up approaches: Non Intensive Follow up approach (Arm A) with no radiologic evaltuations scheduled, but required only at the occurence of any signs or symptoms and Intensive Follow up approach (Arm B) with scheduled radiologic evaluations. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Scheduled radiologic evaluations Start Date: 2014-06 Last Updated: 2023-03-13 Number of Patients: 330 Recruitment Status: SUSPENDED Condition: Head and Neck Cancer
NCTID: NCT00562965
Title: Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator’s Choice In Follicular Non-Hodgkin’s Lymphoma (NHL) Study Summary: This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator’s choice therapy. Subjects will be randomized to one of these two arms of the study. Sponsor: Pfizer Intervention: inotuzumab ozogamicin Start Date: 2007-11 Last Updated: 2018-01-09 Number of Patients: 29 Recruitment Status: TERMINATED Condition: Lymphoma, Follicular
NCTID: NCT02099188
Title: Multidisciplinary Approach for Poor Prognosis Sinonasal Tumors in Inoperable Patients Study Summary: Sinonasal tumors are rare diseases, as they account for the 0.2 % - 0.8 % of all tumors. For patients with inoperable tumors, the prognosis is poor and the current therapy is a combined-modality treatment that is both more effective and associated with less morbidity. This study proposes innovative integration of multiple modality of treatment modulated by histology, molecular profile and response to induction CT. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: Cisplatin Start Date: 2013-11 Last Updated: 2023-03-13 Number of Patients: 27 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Unresectable Sinonasal Tumors
NCTID: NCT01454089
Title: A Phase 2 Study Comparing Chemotherapy in Combination With OGX-427 or Placebo in Patients With Bladder Cancer Study Summary: The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm. Sponsor: Achieve Life Sciences Intervention: OGX-427 600 mg Start Date: 2011-10 Last Updated: 2016-10-07 Number of Patients: 183 Recruitment Status: COMPLETED Condition: Urologic Neoplasms
NCTID: NCT01822314
Title: Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer Study Summary: The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin, Cyclophosphamide (AC) or Epirubicin, Cyclophosphamide (EC) or Fluorouracil,Epirubicin,Cyclophosphamide (FEC)compared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery. Sponsor: Fondazione Michelangelo Intervention: Abraxane Start Date: 2013-04 Last Updated: 2023-02-15 Number of Patients: 632 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT03031483
Title: Clarithromycin + Lenalidomide Combination: a Full Oral Treatment for Patients With Relapsed/Refractory Extranodal Marginal Zone Lymphoma Study Summary: Patients with lymphoid tissue lymphoma mucosa-associated (MALT) for which the standard treatments with radiotherapy, chemotherapy and / or immunotherapy show lack of efficacy Sponsor: International Extranodal Lymphoma Study Group (IELSG) Intervention: clarithromycin and lenalidomide Start Date: 2017-04-03 Last Updated: 2022-11-07 Number of Patients: 44 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mucosa Associated Lymphoid Tissue (MALT) Lymphoma
NCTID: NCT03229200
Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. Study Summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Sponsor: Pharmacyclics Switzerland GmbH Intervention: Ibrutinib Start Date: 2017-05-22 Last Updated: 2023-11-24 Number of Patients: 600 Recruitment Status: ENROLLING_BY_INVITATION Condition: Lymphoma, B-Cell
NCTID: NCT02303821
Title: Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia Study Summary: The purpose of Phase 1b of this study is to: * Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy. The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2015-02-16 Last Updated: 2023-10-23 Number of Patients: 130 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukemia (ALL)
NCTID: NCT02923921
Title: Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer Study Summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival. Sponsor: Eli Lilly and Company Intervention: Pegilodecakin Start Date: 2017-03-01 Last Updated: 2020-10-19 Number of Patients: 567 Recruitment Status: COMPLETED Condition: Pancreatic Cancer
NCTID: NCT04513925
Title: A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Study Summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2020-08-24 Last Updated: 2023-11-03 Number of Patients: 829 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer (NSCLC)
NCTID: NCT03523585
Title: DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] Study Summary: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan Start Date: 2018-08-01 Last Updated: 2023-06-26 Number of Patients: 608 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05519085
Title: A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Study Summary: The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure. Sponsor: Celgene Intervention: mezigdomide Start Date: 2022-09-20 Last Updated: 2023-11-13 Number of Patients: 810 Recruitment Status: RECRUITING Condition: Relapsed or Refractory Multiple Myeloma
NCTID: NCT03003325
Title: The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV Study Summary: The Low-PV study is a multicenter, phase II, randomized trial aimed to assess whether the addition of Pegylated Proline-interferon-alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicylic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk of thrombosis (younger than 60 years and without prior vascular events), in term of control of recommended level of hematocrit < 45%, over a period of 12 months. Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: AOP2014 Start Date: 2017-02-02 Last Updated: 2023-08-03 Number of Patients: 127 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT03720561
Title: A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting Study Summary: The purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in Italian routine clinical practice. Sponsor: Janssen-Cilag S.p.A. Intervention: Ibrutinib Start Date: 2018-10-30 Last Updated: 2022-01-03 Number of Patients: 312 Recruitment Status: COMPLETED Condition: Leukemia, Lymphocytic, Chronic, B-Cell
NCTID: NCT05186753
Title: (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis Study Summary: This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with nonadvanced systemic mastocytosis (NonAdvSM), including indolent systemic mastocytosis and smoldering systemic mastocytosis, whose symptoms are not adequately controlled by BSC. This study will be conducted in three parts. Patients in Parts 1a, 1b and 2 will receive bezuclastinib or placebo, and may roll over onto Part 3 to receive treatment with bezuclastinib. Sponsor: Cogent Biosciences, Inc. Intervention: Bezuclastinib Tablets (Formulation A) Start Date: 2022-06-27 Last Updated: 2023-10-30 Number of Patients: 138 Recruitment Status: RECRUITING Condition: SSM
NCTID: NCT01949129
Title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia Study Summary: The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups. Sponsor: St. Anna Kinderkrebsforschung Intervention: VP16 Start Date: 2013-04 Last Updated: 2020-10-01 Number of Patients: 1000 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukaemia
NCTID: NCT03871829
Title: Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Study Summary: The purpose of this study is to compare the efficacy (rate of very good partial response <math display="block">VGPR</math> or better as best response as defined by the International Myeloma Working Group <math display="block">IMWG</math> criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment. Sponsor: Janssen Research & Development, LLC Intervention: Carfilzomib 20 mg/m^2 Start Date: 2019-05-31 Last Updated: 2023-03-08 Number of Patients: 88 Recruitment Status: TERMINATED Condition: Multiple Myeloma
NCTID: NCT01909453
Title: Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma Study Summary: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: # LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or # vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: # LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or # LGX818 300 mg QD monotherapy (denoted as LGX818 arm) Sponsor: Pfizer Intervention: LGX818 Start Date: 2013-12-13 Last Updated: 2023-09-07 Number of Patients: 921 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT04392960
Title: Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis Study Summary: This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment. Sponsor: IRCCS Policlinico S. Matteo Intervention: [18F]Florbetaben Start Date: 2020-07-22 Last Updated: 2023-06-06 Number of Patients: 69 Recruitment Status: RECRUITING Condition: AL Amyloidosis
NCTID: NCT03568929
Title: Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma Study Summary: The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2018-05-25 Last Updated: 2021-11-19 Number of Patients: 257 Recruitment Status: COMPLETED Condition: Follicular Non-Hodgkin’s Lymphoma Refractory
NCTID: NCT05601973
Title: AMAZE-lung: Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI Study Summary: AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In addition, the safety of the treatment combination will be evaluated. Sponsor: ETOP IBCSG Partners Foundation Intervention: Amivantamab Start Date: 2023-03-27 Last Updated: 2023-08-21 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT06070961
Title: Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines’-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance Study Summary: This is a prospective biological study evaluating the persistence of COVID-19 vaccine and other vaccines’ (zoster, diphtheria and tetanus)-induced immunity in a subgroup patient affected by Follicular Lymphoma requiring treatment undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL_FOLL19 study (NCT05058404). Blood samples from patients will be collected before and at planned timepoints during treatment to evaluate humoral and cellular immunity against SARS-COV-2, VZV, tetanus and diphtheria and T-cell markers characterization. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Cellular immunity vs SARS-CoV-2 Start Date: 2023-12 Last Updated: 2023-10-12 Number of Patients: 56 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT04790253
Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) Study Summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Prophylactic cranial irradiation Start Date: 2022-10-27 Last Updated: 2023-11-03 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT01737177
Title: Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL Study Summary: This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Bendamustine, Lenalidomide, Rituximab Start Date: 2012-07-31 Last Updated: 2018-03-09 Number of Patients: 42 Recruitment Status: COMPLETED Condition: Mantle Cell Lymphoma
NCTID: NCT02811861
Title: Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma Study Summary: The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review <math display="block">IIR</math> using Response Evaluation Criteria in Solid Tumors <math display="block">RECIST 1.1</math>) as first-line treatment in participants with advanced renal cell carcinoma (RCC). Sponsor: Eisai Inc. Intervention: Lenvatinib Start Date: 2016-10-13 Last Updated: 2023-07-10 Number of Patients: 1069 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma
NCTID: NCT01197560
Title: Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Study Summary: The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2010-09-02 Last Updated: 2019-11-25 Number of Patients: 111 Recruitment Status: COMPLETED Condition: Diffuse Large B-cell Lymphoma
NCTID: NCT03024996
Title: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy Study Summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-03 Last Updated: 2023-08-03 Number of Patients: 778 Recruitment Status: TERMINATED Condition: Renal Cell Carcinoma
NCTID: NCT03521596
Title: Non-invasive Diagnostics and Monitoring of MRD and Clonal Evolution in Waldenström’s Macroglobulinemia and in IgM-MGUS Study Summary: Multicenter retrospective and prospective observational study including patients with WM or IgM-MGUS evaluated at the time of diagnosis and during the disease course using highly sensitive techniques. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: MRD and clonal evolution Start Date: 2018-08-28 Last Updated: 2023-04-18 Number of Patients: 300 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Waldenstrom Macroglobulinemia
NCTID: NCT01814488
Title: A Phase II Study on Allogeneic Stem Cell Transplantation in Patients With Active Acute Leukemia Study Summary: The experimental treatment consists in the application of a therapeutic strategy of allogeneic transplantation as a potential curative procedure in a population of patients with chemoresistant acute leukemias. Therapeutic intervention, namely the conditioning regimen as well as GVHD prophylaxis, are based on regimens currently in standard use in the context of allogeneic transplantation. Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: allogeneic transplant Start Date: 2013-07 Last Updated: 2023-03-10 Number of Patients: 101 Recruitment Status: COMPLETED Condition: Acute Leukemia
NCTID: NCT04625023
Title: A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer Study Summary: METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology. METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials. Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology Intervention: Observational Start Date: 2020-07-16 Last Updated: 2023-09-28 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT05298423
Title: Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006) Study Summary: This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: * progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. * overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants. Sponsor: Merck Sharp & Dohme LLC Intervention: pembrolizumab/vibostolimab Start Date: 2022-05-03 Last Updated: 2023-11-24 Number of Patients: 784 Recruitment Status: RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01021423
Title: A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). Study Summary: A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2010-04-01 Last Updated: 2019-11-19 Number of Patients: 9 Recruitment Status: TERMINATED Condition: Mantle Cell Lymphoma
NCTID: NCT03260894
Title: Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302) Study Summary: The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to sunitinib or pazopanib in participants with locally advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not received prior systemic therapy for their mRCC. Sponsor: Incyte Corporation Intervention: Pembrolizumab Start Date: 2017-12-07 Last Updated: 2023-10-26 Number of Patients: 129 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Renal Cell Carcinoma (RCC)
NCTID: NCT03474458
Title: A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based Therapy Study Summary: Systemic amyloidoses are rare diseases affecting approximately 1 in 100,000 persons each year. In systemic amyloidoses abnormal proteins deposit in bodily organs and severely impair their function, causing death if not treated effectively. Light chain (AL) amyloidosis is caused by a usually small population of plasma cells (the cells that produce antibodies). These cells produce part of antibodies, the light chains (LC) that form amyloid deposits. Almost every organ, with the exception of the brain, can be affected by AL amyloidosis. The heart is involved in three fourths of patients and is responsible for almost all the deaths occurring in the first 6 months after diagnosis. Current therapy of AL amyloidosis is based on drugs targeting the plasma cells producing the amyloid-forming LC. At present, most patients receive a powerful anti-plasma cell drug, bortezomib, as part of their initial treatment. However, bortezomib-based therapy, can improve heart involvement only in less than one third of patients with AL amyloidosis, and many patients (approximately one third) still die within 12 months from diagnosis. Early cardiac deaths remain an acute unmet need and the major determinant of overall outcome in this disease. Thus, there is the need of alternative means to treat heart involvement in AL amyloidosis. Doxycycline is a widely used, well tolerated, antibiotic that has been marketed for decades and used to treat a number of different infectious diseases caused by bacteria. This molecule has been extensively studied in the laboratory, in animal models and, more recently, in small studies involving patients, for its potential of improving cardiac damage in amyloidosis. These studies showed that doxycycline disrupts amyloid deposits, reduces the amyloid load in a mouse model, and counteracts the toxicity exerted by amyloid-forming LCs on C. elegans, a worm whose pharynx is used as a model resembling human heart. In a small clinical study, doxycycline was given to patients with cardiac AL amyloidosis during treatment for their underlying plasma cell disease. This resulted in a remarkable improvement of survival compared to “matched historical controls” (i.e. similar patients who had received only anti-plasma cell therapy without doxycycline in the past). Based on these promising preliminary results, we designed the present clinical trial to assess whether the addition of doxycycline to anti-plasma cell therapy can improve survival in patients with cardiac AL amyloidosis who were not previously treated. The rate of survival at 12 months will be compared in patients receiving doxycycline and in controls receiving standard antibiotic therapy, together with anti-plasma cell therapy. Patients will be assessed for parameters of plasma cell disease, heart involvement and possible involvement of other organs, as well as for quality of life. To make sure that patients who will receive doxycycline and those who will not have comparable severity of cardiac disease, patients will be stratified according to the stage of cardiac involvement. Patients with very advanced heart dysfunction will not be enrolled in the trial, because preliminary data indicate that doxycycline is of little or no benefit in these subjects. Patients will be randomized to receive doxycycline or standard antibiotics in combination with anti-plasma cell therapy. Bortezomib-based treatment directed against plasma cells will be delivered according to each participating institutions’ guidelines. Doxycycline will be administered at a dosage of 100 mg two times a day, which is usual in the treatment of bacterial diseases. Standard antibiotics will be delivered according to each participating institutions’ guidelines (provided that drugs of the same class as doxycycline are not administered) in the control arm. Patients will be provided a diary to record possible adverse events and will be instructed accordingly. Patients will be evaluated at trial centers every 2 months for treatment efficacy and toxicity. In case of unsatisfactory response second-line therapy will be initiated. In the absence of unacceptable toxicity, doxycycline administration will be continued for the entire duration of follow-up (12 months). Sponsor: IRCCS Policlinico S. Matteo Intervention: Doxycycline Start Date: 2019-02-11 Last Updated: 2023-10-02 Number of Patients: 19 Recruitment Status: TERMINATED Condition: Cardiac AL Amyloidosis
NCTID: NCT05011058
Title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas Study Summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas Sponsor: Viracta Therapeutics, Inc. Intervention: Nanatinostat in combination with valganciclovir Start Date: 2021-05-28 Last Updated: 2023-11-27 Number of Patients: 140 Recruitment Status: RECRUITING Condition: Epstein-Barr Virus Associated Lymphoproliferative Disorder
NCTID: NCT02367794
Title: A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131] Study Summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody Start Date: 2015-06-11 Last Updated: 2022-03-21 Number of Patients: 1021 Recruitment Status: COMPLETED Condition: Squamous Non-Small Cell Lung Cancer
NCTID: NCT03545035
Title: Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study Study Summary: The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: idelalisib and rituximab Start Date: 2019-02-06 Last Updated: 2022-05-12 Number of Patients: 104 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT02917772
Title: Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Renal Cell Carcinoma Study Summary: TITAN RCC (0216-ASG) is a Phase 2, open-label study of nivolumab monotherapy with additional nivolumab/ipilimumab “boost” cycles in previously untreated and pretreated (2nd line), advanced or metastatic renal cell carcinoma (mRCC) subjects with intermediate and high risk disease according to IMDC. Sponsor: AIO-Studien-gGmbH Intervention: Nivolumab/Ipilimumab Start Date: 2016-10 Last Updated: 2022-10-06 Number of Patients: 200 Recruitment Status: COMPLETED Condition: Carcinoma, Renal Cell
NCTID: NCT03804372
Title: The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide Study Summary: In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Rituximab Start Date: 2020-07-07 Last Updated: 2022-01-04 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Large-B-cell Diffuse Lymphoma
NCTID: NCT03934372
Title: Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors Study Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors. Sponsor: Incyte Biosciences International Sàrl Intervention: Ponatinib Start Date: 2020-01-29 Last Updated: 2023-10-23 Number of Patients: 60 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT03610438
Title: Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia Study Summary: This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation. The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Inotuzumab Ozogamicin (IO) Start Date: 2019-10-30 Last Updated: 2022-01-04 Number of Patients: 76 Recruitment Status: RECRUITING Condition: Acute Lymphoid Leukemia
NCTID: NCT00678392
Title: Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer Study Summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen. Sponsor: Pfizer Intervention: Axitinib (AG-013736) Start Date: 2008-09-03 Last Updated: 2019-01-09 Number of Patients: 723 Recruitment Status: COMPLETED Condition: Kidney Neoplasms
NCTID: NCT02836925
Title: Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection Study Summary: This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Ledipasvir+Sofosbuvir Start Date: 2016-03 Last Updated: 2023-03-31 Number of Patients: 40 Recruitment Status: COMPLETED Condition: Indolent B-cell Lymphoma
NCTID: NCT04712292
Title: Effects of COVID-19 Pandemic on the Outcomes of Colorectal Cancer Study Summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been identified as the cause of the Coronavirus disease 19 (COVID-19), which was initially reported in December 2019 in China and has since rapidly spread worldwide. Since then, the COVID-19 pandemic has caused a detrimental effect of the national health care system, causing a drastic reduction of the screening programs for colorectal cancer and requiring the redistribution of the hospital resources from elective surgery to the care of patients with SARS-Cov_2 infection requiring admission. Sponsor: University of Bologna Intervention: Surgical procedure for confirmed or suspected colorectal cancer Start Date: 2020-09-08 Last Updated: 2022-02-28 Number of Patients: 15000 Recruitment Status: RECRUITING Condition: Colorectal Neoplasms Malignant
NCTID: NCT02398825
Title: Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib Study Summary: This study aims at evaluating the efficacy of treatment with ponatinib in patients with chronic myeloid leukemia who are in a chronic phase and who previously received treatment with imatinib but resulted to be resistant to it. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ponatinib Start Date: 2016-06-23 Last Updated: 2022-01-05 Number of Patients: 16 Recruitment Status: UNKNOWN Condition: Chronic Myeloid Leukemia
NCTID: NCT02626455
Title: Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL) Study Summary: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine <math display="block">R-B</math> and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone <math display="block">R-CHOP</math>) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents. Sponsor: Bayer Intervention: Copanlisib (BAY80-6946) Start Date: 2016-01-06 Last Updated: 2023-10-12 Number of Patients: 551 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Non-Hodgkin
NCTID: NCT05384873
Title: Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer Study Summary: The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling Sponsor: IRCCS Policlinico S. Matteo Intervention: Immunonutrition Start Date: 2023-06-01 Last Updated: 2023-11-22 Number of Patients: 180 Recruitment Status: RECRUITING Condition: Lung Cancer, Nonsmall Cell
NCTID: NCT06037980
Title: CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence Study Summary: PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence. Sponsor: Gruppo Oncologico del Nord-Ovest Intervention: Gemcitabine Start Date: 2023-11-07 Last Updated: 2023-11-15 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Biliary Tract Cancer
NCTID: NCT02859324
Title: A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC) Study Summary: CC-122-HCC-002 is a Phase 1/2 dose escalation and expansion clinical study of CC-122 in combination with nivolumab in subjects with unresectable hepatocellular carcinoma (HCC) who have progressed after or were intolerant to no more than 2 previous systemic therapies for unresectable HCC, or are naïve to systemic therapy. Sponsor: Celgene Intervention: CC-122 Start Date: 2016-09-20 Last Updated: 2021-05-11 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Carcinoma, Hepatocellular
NCTID: NCT04384484
Title: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Study Summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy. Sponsor: ADC Therapeutics S.A. Intervention: Loncastuximab Tesirine Start Date: 2020-09-16 Last Updated: 2023-09-21 Number of Patients: 350 Recruitment Status: RECRUITING Condition: Relapsed Diffuse Large B-Cell Lymphoma
NCTID: NCT03529110
Title: DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Study Summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Sponsor: Daiichi Sankyo, Inc. Intervention: Trastuzumab deruxtecan (T-DXd) Start Date: 2018-08-09 Last Updated: 2023-02-09 Number of Patients: 524 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT04455841
Title: INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders Study Summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion. Sponsor: Incyte Corporation Intervention: INCB000928 Start Date: 2021-03-19 Last Updated: 2023-11-24 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Anemia
NCTID: NCT04168502
Title: Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML Study Summary: MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD. Role of a post-SCT maintenance with glasdegib. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Glasdegib Start Date: 2020-09-24 Last Updated: 2022-07-20 Number of Patients: 414 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia
NCTID: NCT03745378
Title: Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study) Study Summary: The incidence of secondary cancer (SC) in patients with myeloproliferative neoplasms (MPN) is high and comparable to that of thrombosis. However, the identification of patient subgroups that might be at increased susceptibility of developing SC has not been systematically addressed. This international case-control study (MPN-K) is aimed to elucidate the prognostic role of JAK2V617F mutation in predicting the occurrence of SC in patients with classical MPN, polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF) Sponsor: Fondazione per la Ricerca Ospedale Maggiore Intervention: JAK2V617F mutation Start Date: 2018-05-15 Last Updated: 2019-12-06 Number of Patients: 1881 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT01901432
Title: A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Study Summary: This is a two-part, multicenter, open label, non-randomized, phase Ib/II study to assess the safety and tolerability, Maximum Tolerated Dose and preliminary efficacy of Givinostat in patients with JAK2V617F positive Polycythemia Vera. Part A is the dose finding part while Part B is assessing the preliminary efficacy. Patients will be enrolled either in Part A or Part B and transition from one part to the other is not allowed. Eligible patients for this study will have a confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization criteria. Only if the enrolment in Part A is slow (i.e. < 5 patients enrolled in 3 months), eligibility for this part of the study may be expanded to all patients with chronic myeloproliferative neoplasms. Study therapy will be administered in 28 day cycles (4 weeks of treatment). Disease response will be evaluated according to the European LeukemiaNet criteria after 3 and 6 cycles (i.e. at weeks 12 and 24, respectively) of treatment with Givinostat for both parts of the study. All phlebotomies performed in the first 3 weeks of treatment will not be counted to assess the clinico-haematological response. The study will last up to a maximum of 24 weeks of treatment. However, after completion of the trial, all patients achieving clinical benefit will be allowed to continue treatment with Givinostat (at the same dose and schedule) in a long-term study. Safety will be monitored at each visit throughout the entire duration of the study. Treatment will be administered on an outpatient basis and patients will be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalization, the treatment will be continued or interrupted according to the Investigators’ decision. Sponsor: Italfarmaco Intervention: Givinostat Start Date: 2013-10 Last Updated: 2019-07-30 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Polycythemia Vera
NCTID: NCT04569032
Title: A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression Study Summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL. Sponsor: Seagen Inc. Intervention: brentuximab vedotin Start Date: 2020-11-12 Last Updated: 2023-11-14 Number of Patients: 80 Recruitment Status: RECRUITING Condition: Peripheral T-cell Lymphoma
NCTID: NCT04502394
Title: Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy) Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2021-02-23 Last Updated: 2022-08-04 Number of Patients: 84 Recruitment Status: RECRUITING Condition: Diffuse Large B Cell Lymphoma
NCTID: NCT02607202
Title: A Study of Nab-paclitaxel-based Doublet as First Line Therapy in Patients With Cancer of Unknown Primary (CUP) Study Summary: Agnostos Trial is a multicentric phase 2 randomized trial with a ‘pick-the-winner design’ in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens. Sponsor: Fondazione del Piemonte per l’Oncologia Intervention: nab-paclitaxel Start Date: 2015-03 Last Updated: 2017-09-05 Number of Patients: 120 Recruitment Status: UNKNOWN Condition: Unknown Primary Tumors
NCTID: NCT05490446
Title: A Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) Study Summary: This purpose of this study is to establish proof of concept of AG-946 in participants with LR-MDS in Phase 2a and to compare the effect of AG-946 versus placebo and to detect a dose response for erythroid response in participants with LR-MDS in Phase 2b. Sponsor: Agios Pharmaceuticals, Inc. Intervention: AG-946 Start Date: 2022-11-07 Last Updated: 2023-11-14 Number of Patients: 116 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelodysplastic Syndromes
NCTID: NCT05160584
Title: A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma Study Summary: The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma. Sponsor: Janssen Pharmaceutica N.V., Belgium Intervention: No intervention Start Date: 2021-11-18 Last Updated: 2023-11-09 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Relapsed/Refractory Multiple Myeloma
NCTID: NCT02858258
Title: ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma Study Summary: The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival. Sponsor: Prof. Dr. M. Dreyling (co-chairman) Intervention: R-CHOP/R-DHAP Start Date: 2016-07 Last Updated: 2017-12-19 Number of Patients: 870 Recruitment Status: RECRUITING Condition: Mantle Cell Lymphoma
NCTID: NCT04835584
Title: KRT-232 and TKI Study in Chronic Myeloid Leukemia Study Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments. Sponsor: Kartos Therapeutics, Inc. Intervention: KRT-232 Start Date: 2021-05-07 Last Updated: 2022-03-21 Number of Patients: 109 Recruitment Status: RECRUITING Condition: Chronic Myeloid Leukemia
NCTID: NCT00879528
Title: Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory Study Summary: PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin’s lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Patients with negative PET after salvage therapy Start Date: 2009-05 Last Updated: 2016-08-17 Number of Patients: 264 Recruitment Status: TERMINATED Condition: Hodgkin’s Lymphoma
NCTID: NCT02517398
Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors Study Summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: MSB0011359C Start Date: 2015-08-31 Last Updated: 2022-06-15 Number of Patients: 600 Recruitment Status: COMPLETED Condition: Solid Tumors
NCTID: NCT02158858
Title: A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis Study Summary: Phase 1 Part (Complete): Open-label, sequential dose escalation study of pelabresib in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis. Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis. CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Sponsor: Constellation Pharmaceuticals Intervention: Pelabresib (CPI-0610) Start Date: 2014-07-29 Last Updated: 2022-12-07 Number of Patients: 341 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT05287113
Title: Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Study Summary: The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). Sponsor: Incyte Biosciences International Sàrl Intervention: Retifanlimab Start Date: 2022-11-14 Last Updated: 2023-11-09 Number of Patients: 162 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT03643276
Title: Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 Study Summary: The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response (“minimal residual disease <math display="block">MRD</math> tests”) has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup. Sponsor: Martin Schrappe Intervention: Blinatumomab Start Date: 2018-07-15 Last Updated: 2023-11-29 Number of Patients: 5000 Recruitment Status: RECRUITING Condition: Acute Lymphoblastic Leukemia, Pediatric
NCTID: NCT03112174
Title: Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO) Study Summary: This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL. Sponsor: Pharmacyclics LLC. Intervention: Ibrutinib Start Date: 2017-06-29 Last Updated: 2023-09-28 Number of Patients: 352 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Mantle-Cell Lymphoma
NCTID: NCT00607581
Title: Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis Study Summary: The treatment of light-chain (AL) amyloidosis is directed against the plasma cells that produce the light-chain forming the amyloid deposits. The plasma cells can be killed and their growth can be stopped by drugs used in chemotherapy, such as cyclophosphamide, steroids, such as dexamethasone, and drugs that stimulate the immune system, such as lenalidomide. The present trial studies the efficacy and safety of the combination of cyclophosphamide, lenalidomide and dexamethasone in patients with AL amyloidosis who were previously treated and need further therapy. Sponsor: IRCCS Policlinico S. Matteo Intervention: cyclophosphamide Start Date: 2008-02 Last Updated: 2012-02-10 Number of Patients: 21 Recruitment Status: COMPLETED Condition: Amyloidosis
NCTID: NCT04364776
Title: Radiomic Signature as Predictive Marker of Response to Chemoradiation and Durvalumab in Stage III NSCLC. Study Summary: The introduction of maintenance immunotherapy with the anti PD-L1 inhibitor durvalumab opened a new therapeutic window for stage III NSCLC patients who achieve at least stable disease after chemo-radiation, as shown by the randomized phase 3 PACIFIC study. However, still half of the patients do progress at 12 months (up to 70% at 18 months). In this study, the investigators aim to test a non-invasive image-based approach, namely a “radiomics” platform, as a tool to define a higher or lower likelihood of response to chemo-radiation and durvalumab. For this purpose, we will retrospectively and prospectively collect and analyze a cohort of at least 70 stage III NSCLC patients treated with CT-RT followed by maintenance durvalumab. Sponsor: IRCCS Policlinico S. Matteo Intervention: Durvalumab Start Date: 2020-01-15 Last Updated: 2023-09-28 Number of Patients: 100 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lung Cancer
NCTID: NCT01578213
Title: Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients Study Summary: The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months. Sponsor: University of Milano Bicocca Intervention: Imatinib mesylate Start Date: 2011-11-09 Last Updated: 2019-12-03 Number of Patients: 112 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT02181413
Title: A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant Study Summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response <math display="block">CR</math>, very good partial response <math display="block">VGPR</math>, or partial response <math display="block">PR</math>) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT). Sponsor: Takeda Intervention: Ixazomib Citrate Start Date: 2014-07-01 Last Updated: 2023-09-13 Number of Patients: 656 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Multiple Myeloma
NCTID: NCT04148911
Title: A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer Study Summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2019-12-17 Last Updated: 2023-09-21 Number of Patients: 184 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple-Negative Breast Cancer
NCTID: NCT03040999
Title: Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412) Study Summary: The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS). Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2017-04-05 Last Updated: 2023-06-08 Number of Patients: 804 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Head and Neck Neoplasms
NCTID: NCT05720936
Title: In-hospital Stellate Ganglion Block for Arrhythmic Storm Study Summary: Arrhythmic storm is a real emergency and its treatment could be challenging. Antiarrhythmic drugs are few and often ineffective. Neuromodulation has been grown in evidences but no large multicentric studies are present in literature about safety and effectiveness of Percutaneous Stellate Ganglion Block (PSGB). Patients with an electrical storm refractory to at least one antiarrhythmic drug will receive PSGB and will be enrolled in the present study. The number of defibrillations before and after the treatment will be compared, complications will be annotated. Sponsor: IRCCS Policlinico S. Matteo Intervention: Percutaneous stellate ganglion block (PSGB) Start Date: 2017-01 Last Updated: 2023-03-03 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Arrhythmic Storm
NCTID: NCT02841540
Title: A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes Study Summary: A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia Sponsor: Hemavant Sciences GmbH Intervention: H3B-8800 (RVT-2001) Start Date: 2016-10-06 Last Updated: 2023-09-29 Number of Patients: 200 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Myeloid, Acute
NCTID: NCT03647124
Title: A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma Study Summary: The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma. Sponsor: Celgene Intervention: Lenalidomide Start Date: 2019-03-13 Last Updated: 2022-10-21 Number of Patients: 560 Recruitment Status: RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: NCT04621201
Title: Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas Study Summary: Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations. Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant’Anna Intervention: observation and biopsy Start Date: 2018-12-06 Last Updated: 2023-03-29 Number of Patients: 120 Recruitment Status: RECRUITING Condition: Diagnosed or Relapsed/Refractory Sarcomas
NCTID: NCT05089734
Title: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Study Summary: The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy (SG) Start Date: 2021-11-17 Last Updated: 2023-06-29 Number of Patients: 580 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-Small Cell Lung Cancer
NCTID: NCT01117441
Title: International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia Study Summary: Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: * Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 <0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? * Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? * High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: * Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? * T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? * HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase “MRD Non-Responders”: Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? * Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? * What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol? Sponsor: University Hospital Schleswig-Holstein Intervention: PEG-L-asparaginase Start Date: 2010-06 Last Updated: 2022-05-24 Number of Patients: 6136 Recruitment Status: COMPLETED Condition: Leukemia
NCTID: NCT01178281
Title: Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence Study Summary: The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only) Sponsor: Celgene Intervention: Pomalidomide 0.5 mg Start Date: 2010-09-08 Last Updated: 2019-07-17 Number of Patients: 267 Recruitment Status: COMPLETED Condition: Primary Myelofibrosis
NCTID: NCT01287741
Title: A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA) Study Summary: This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks. Sponsor: Hoffmann-La Roche Intervention: Rituximab Start Date: 2011-07-26 Last Updated: 2019-04-12 Number of Patients: 1418 Recruitment Status: TERMINATED Condition: Diffuse Large B-Cell Lymphoma
NCTID: NCT03528941
Title: The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib Study Summary: This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Lamivudine Start Date: 2018-11-28 Last Updated: 2022-05-12 Number of Patients: 109 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04022876
Title: A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Study Summary: This is a Phase 1b, multicenter, 2-part study of ALRN-6924 for the prevention of chemotherapy-induced side effects. Part 1 SCLC is an open-label, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated ED SCLC undergoing 2nd-line treatment with topotecan. (Part 1 has completed enrollment). Part 2 NSCLC is a randomized, double-blind, placebo-controlled, multicenter study of ALRN-6924 for the prevention of chemotherapy-induced side effects in patients with p53-mutated advanced NSCLC of adenocarcinoma histology receiving 1st-line treatment with carboplatin plus pemetrexed with or without immunotherapy. Sponsor: Aileron Therapeutics, Inc. Intervention: ALRN-6924 Start Date: 2019-09-03 Last Updated: 2022-10-10 Number of Patients: 35 Recruitment Status: TERMINATED Condition: Non Small Cell Lung Cancer
NCTID: NCT02247869
Title: Dose-dense ABVD First Line Therapy in Early Stage Unfavorable Hodgkin’s Lymphoma Study Summary: Prospective, multicenter, Phase II trial designed to assess whether intensification of ABVD (dd-ABVD) is feasible and can improve the outcome of patients with early stage Hodgkin Lymphoma. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: dose dense ABVD Start Date: 2012-02 Last Updated: 2018-02-09 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Hodgkin Lymphoma
NCTID: NCT02631070
Title: A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes Study Summary: The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study to determine the efficacy and safety of luspatercept (ACE-536) versus placebo in participants with anemia due to the Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate MDS with ring sideroblasts who require red blood cell (RBC) transfusions. Sponsor: Celgene Intervention: Luspatercept Start Date: 2016-02-09 Last Updated: 2021-12-17 Number of Patients: 229 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndromes
NCTID: NCT04611113
Title: Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer Study Summary: The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck Sponsor: IRCCS Policlinico S. Matteo Intervention: Immunonutrition Start Date: 2021-03-17 Last Updated: 2022-05-05 Number of Patients: 86 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT02354313
Title: Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients Study Summary: A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Lenalidomide Start Date: 2010-05 Last Updated: 2018-02-09 Number of Patients: 300 Recruitment Status: UNKNOWN Condition: MANTLE CELL LYMPHOMA
NCTID: NCT02492711
Title: Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Study Summary: The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy. Sponsor: MacroGenics Intervention: Margetuximab Start Date: 2015-08-24 Last Updated: 2022-11-23 Number of Patients: 624 Recruitment Status: COMPLETED Condition: HER-2 Positive Breast Cancer
