Trials (IRCCS Ospedale Policlinico San Martino)
From Beacon
Go back to IRCCS Ospedale Policlinico San Martino page
NCTID: NCT05291156
Title: CAVE-2 GOIM Study: a Clinical Study of the Combination of Avelumab Plus Cetuximab as Rechallenge Strategy Study Summary: This is a non-profit phase II, randomized clinical study of the combination of avelumab plus cetuximab as rechallenge strategy, compared to cetuximab alone, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in first line with chemotherapy in combination with cetuximab and have had a clinical benefit (complete or partial response) from treatment. Sponsor: University of Campania “Luigi Vanvitelli” Intervention: Cetuximab Start Date: 2022-07-21 Last Updated: 2023-10-04 Number of Patients: 173 Recruitment Status: RECRUITING Condition: Metastatic Colorectal Cancer
NCTID: NCT03755856
Title: Long-term Outcomes for Acute Myeloid Leukemia Patients Study Summary: This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Questionnaire Start Date: 2019-05-16 Last Updated: 2020-03-04 Number of Patients: 343 Recruitment Status: UNKNOWN Condition: Acute Myeloid Leukemia
NCTID: NCT04576156
Title: A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment Study Summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment. Sponsor: Geron Corporation Intervention: Imetelstat Start Date: 2021-04-12 Last Updated: 2023-11-28 Number of Patients: 320 Recruitment Status: RECRUITING Condition: Myelofibrosis
NCTID: NCT02810990
Title: Bosutinib in Elderly Chronic Myeloid Leukemia Study Summary: The objective of the present study is to evaluate a new drug called bosutinib as it is believed that this agent may be able to predict an excellent prognosis in patients that did not obtain any benefit with other drugs before. Still, this needs to be proved and we hope this study is able to do so. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Bosutinib Start Date: 2016-11-17 Last Updated: 2023-02-03 Number of Patients: 65 Recruitment Status: COMPLETED Condition: Chronic Myeloid Leukemia
NCTID: NCT03771456
Title: Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery Study Summary: Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy. Sponsor: Ospedale C & G Mazzoni Intervention: Colorectal resections Start Date: 2019-01-07 Last Updated: 2018-12-11 Number of Patients: 1748 Recruitment Status: UNKNOWN Condition: Colorectal Neoplasms
NCTID: NCT03439215
Title: PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer Study Summary: This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria. Sponsor: Fondazione Ricerca Traslazionale Intervention: Lorlatinib Start Date: 2017-06-13 Last Updated: 2021-07-19 Number of Patients: 20 Recruitment Status: UNKNOWN Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT05249959
Title: Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients. Study Summary: This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C)) Start Date: 2022-04-21 Last Updated: 2023-07-21 Number of Patients: 56 Recruitment Status: RECRUITING Condition: Relapsed Mantle Cell Lymphoma
NCTID: NCT02066675
Title: Trabectedin First Line Therapy In Unfit Sarcoma Study Study Summary: Phase II, non-randomized, two-stage study according to Bryant & Day The study enroll patients with Metastatic and locally advanced soft tissue sarcoma unfit to receive standard chemotherapy (doxorubicin/epirubicin and/or ifosfamide) Sponsor: Italian Sarcoma Group Intervention: Trabectedin Start Date: 2014-02 Last Updated: 2018-04-11 Number of Patients: 24 Recruitment Status: COMPLETED Condition: Metastatic and Locally Advanced Soft Tissue Tumor Patients Unfit to Receive
NCTID: NCT05896566
Title: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer Study Summary: PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C). Sponsor: ETOP IBCSG Partners Foundation Intervention: Giredestrant Start Date: 2023-12-01 Last Updated: 2023-10-18 Number of Patients: 220 Recruitment Status: NOT_YET_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: NCT02067143
Title: MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate Study Summary: This study will be conducted in different centres and will study adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study treatment will include a induction/consolidation therapy incorporating pegylated Asparaginase (Peg-ASP) and lineage-targeted high-dose methotrexate plus other antileukemic drugs, for the achievement of an early negative minimal residual disease (MRD) status. The MRD study supports a risk/MRD-oriented final consolidation phase. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Prephase PDN + CY Start Date: 2014-05-20 Last Updated: 2021-09-08 Number of Patients: 204 Recruitment Status: COMPLETED Condition: Untreated Philadelphia Positive Acute Lymphoblastic Leukemia
NCTID: NCT01405586
Title: MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer Study Summary: The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival. Sponsor: National Cancer Institute, Naples Intervention: Gemcitabine Start Date: 2011-03 Last Updated: 2023-03-24 Number of Patients: 299 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer Metastatic
NCTID: NCT02232386
Title: Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia Study Summary: The present study aims at evaluating whether treatment with two different drugs, Ibrutinib and Rituximab is both efficient and safe for newly diagnosed patients with chronic lymphocytic leukemia. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ibrutinib Start Date: 2015-03-02 Last Updated: 2023-11-28 Number of Patients: 156 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronic Lymphocyte Leukemia
NCTID: NCT03745222
Title: A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer Study Summary: This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. . Sponsor: Celgene Intervention: Tislelizumab Start Date: 2019-05-22 Last Updated: 2020-07-15 Number of Patients: 1 Recruitment Status: TERMINATED Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03609047
Title: Adjuvant Palbociclib in Elderly Patients With Breast Cancer Study Summary: Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Palbociclib Start Date: 2019-06-14 Last Updated: 2022-11-17 Number of Patients: 366 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer Stage II
NCTID: NCT05382286
Title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer Study Summary: The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Sponsor: Gilead Sciences Intervention: Sacituzumab Govitecan-hziy Start Date: 2022-07-25 Last Updated: 2023-11-15 Number of Patients: 440 Recruitment Status: RECRUITING Condition: Triple Negative Breast Cancer
NCTID: NCT05063786
Title: Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Study Summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer. Sponsor: Spanish Breast Cancer Research Group Intervention: Trastuzumab Start Date: 2021-09-14 Last Updated: 2023-03-24 Number of Patients: 300 Recruitment Status: RECRUITING Condition: Advanced Breast Cancer
NCTID: NCT02164903
Title: LEONIDAS: Quality of Life Study in Chronic Myeloid Leukemia Patients Study Summary: The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: QoL Survey Booklet Start Date: 2014-09-11 Last Updated: 2018-08-06 Number of Patients: 323 Recruitment Status: UNKNOWN Condition: Chronic Myeloid Leukemia
NCTID: NCT05155254
Title: IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) Study Summary: Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival. Sponsor: IO Biotech Intervention: IO102-IO103 Start Date: 2022-05-17 Last Updated: 2023-09-13 Number of Patients: 380 Recruitment Status: RECRUITING Condition: Metastatic Melanoma
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: NCT01379989
Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer Study Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients. Sponsor: Mario Negri Institute for Pharmacological Research Intervention: Carboplatin Start Date: 2011-06 Last Updated: 2022-02-09 Number of Patients: 617 Recruitment Status: COMPLETED Condition: Ovarian Cancer
NCTID: NCT02348489
Title: SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction Study Summary: To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy. Sponsor: Astex Pharmaceuticals, Inc. Intervention: SGI-110 (guadecitabine) Start Date: 2015-03-19 Last Updated: 2021-01-14 Number of Patients: 815 Recruitment Status: COMPLETED Condition: Leukemia, Myeloid, Acute
NCTID: 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: 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: NCT02582320
Title: Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program Study Summary: This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ibrutinib Start Date: 2016-03 Last Updated: 2021-09-13 Number of Patients: 264 Recruitment Status: COMPLETED Condition: Chronic Lymphocytic Leukemia
NCTID: NCT04459715
Title: A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX) Study Summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Sponsor: EMD Serono Research & Development Institute, Inc. Intervention: Xevinapant (Debio 1143) Start Date: 2020-08-07 Last Updated: 2023-10-24 Number of Patients: 730 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Cell Carcinoma of the Head and Neck
NCTID: NCT02744768
Title: D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia Study Summary: This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Dasatinib Start Date: 2017-05-31 Last Updated: 2018-03-22 Number of Patients: 60 Recruitment Status: UNKNOWN Condition: Acute Lymphoblastic Leukemia
NCTID: NCT01818752
Title: Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma Study Summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP). Sponsor: Amgen Intervention: Carfilzomib Start Date: 2013-07-08 Last Updated: 2019-08-26 Number of Patients: 955 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT03768505
Title: Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL) Study Summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy Sponsor: MEI Pharma, Inc. Intervention: Zandelisib (ME-401) Start Date: 2019-06-25 Last Updated: 2023-05-09 Number of Patients: 169 Recruitment Status: TERMINATED Condition: Follicular Lymphoma (FL)
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: NCT05058404
Title: Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma Study Summary: FIL_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS). Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Immunochemotherapy regimen: Rituximab-bendamustine (Arm A) Start Date: 2021-12-01 Last Updated: 2023-03-09 Number of Patients: 602 Recruitment Status: RECRUITING Condition: Follicular Lymphoma
NCTID: NCT03751917
Title: Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia Study Summary: The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough information on the incidence of long-term side effects. This study, as well as other similar studies conducted around Europe, will focus on following patients treated with this therapy on a long-term basis. Once all studies in Europe will be concluded, all data will be analyzed together. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Arsenic Trioxide Start Date: 2020-04-14 Last Updated: 2022-01-04 Number of Patients: 100 Recruitment Status: RECRUITING Condition: Acute Promyelocytic Leukemia
NCTID: NCT04994717
Title: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia Study Summary: The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy. Sponsor: Amgen Intervention: Blinatumomab Start Date: 2021-11-02 Last Updated: 2023-11-18 Number of Patients: 287 Recruitment Status: RECRUITING Condition: Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
NCTID: NCT04165317
Title: A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer Study Summary: The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. * Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons. Sponsor: Pfizer Intervention: PF-06801591 Start Date: 2019-12-30 Last Updated: 2023-09-01 Number of Patients: 1070 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-muscle Invasive Bladder Cancer
NCTID: NCT02039726
Title: (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive Study Summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Quizartinib Start Date: 2014-05 Last Updated: 2021-02-24 Number of Patients: 367 Recruitment Status: COMPLETED Condition: AML
NCTID: NCT05111626
Title: Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer Study Summary: The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival. Sponsor: Amgen Intervention: Bemarituzumab Start Date: 2022-03-14 Last Updated: 2023-11-27 Number of Patients: 528 Recruitment Status: RECRUITING Condition: Gastric Cancer
NCTID: NCT01732926
Title: Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas Study Summary: The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2013-01-02 Last Updated: 2018-11-16 Number of Patients: 475 Recruitment Status: TERMINATED Condition: Indolent Non-Hodgkin’s Lymphomas
NCTID: 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: NCT02920008
Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia Study Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine <math display="block">HiDAC</math>; mitoxantrone, etoposide, and cytarabine <math display="block">MEC</math>; or fludarabine, cytarabine, granulocyte colony stimulating factor <math display="block">G-CSF</math>, +/- idarubicin <math display="block">FLAG/FLAG-Ida</math>). * Low intensity (low dose cytarabine <math display="block">LDAC</math>, decitabine, or azacitidine). * BSC. Sponsor: Astex Pharmaceuticals, Inc. Intervention: guadecitabine Start Date: 2017-03-16 Last Updated: 2023-05-25 Number of Patients: 302 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT04657991
Title: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma Study Summary: The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called “BRAF”; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. Sponsor: Pfizer Intervention: Encorafenib Start Date: 2021-01-15 Last Updated: 2023-11-07 Number of Patients: 624 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT05816850
Title: Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial Study Summary: This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: EZH2 mutations/CNAs by droplet digital PCR (ddPCR) Start Date: 2023-06-01 Last Updated: 2023-04-18 Number of Patients: 654 Recruitment Status: NOT_YET_RECRUITING Condition: Follicular Lymphoma
NCTID: NCT01706120
Title: Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab Study Summary: The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival. Sponsor: National Cancer Institute, Naples Intervention: Bevacizumab Start Date: 2012-10 Last Updated: 2023-03-24 Number of Patients: 400 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Ovarian Cancer
NCTID: NCT02293707
Title: A Phase II Randomised Trial of Three Regimens of GX301 Vaccination in Castration-resistant Prostate Cancer Study Summary: GX301 is an experimental therapeutic vaccine directed against human telomerase, an enzyme playing an essential role in cancer cell proliferation. This clinical trial will test three different GX301 administration regimens in castration-resistant prostate cancer patients who have achieved response or disease stability with first-line docetaxel treatment. This is aimed at identifying an optimal vaccination regimen. The three regimens will primarily be compared for their efficacy and safety in inducing vaccine-specific immunological responses over a period of 6 months following treatment initiation. In addition, patients will be observed for the occurrence of disease progression and for their vital status up to 24 months. Sponsor: Laboratoires Leurquin Mediolanum Intervention: GX301 Start Date: 2014-11 Last Updated: 2020-07-22 Number of Patients: 99 Recruitment Status: COMPLETED Condition: Prostate Cancer
NCTID: NCT03445533
Title: A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma Study Summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma Sponsor: Idera Pharmaceuticals, Inc. Intervention: Ipilimumab Start Date: 2018-05-30 Last Updated: 2022-11-08 Number of Patients: 481 Recruitment Status: TERMINATED Condition: Metastatic Melanoma
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: NCT02448095
Title: Retrospective Evaluation of CML Patients in the National Compassionate Program Study Summary: This observational study aims at assessing the tolerability and safety profiles of Ponatinib, a drug used for Chronic Myeloid Leukemia patients who are Philadelphia positive. This drug is used during the chronic phase of the disease, according to the Italian national compassionate law 648/96. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ponatinib Start Date: 2015-12-22 Last Updated: 2022-10-26 Number of Patients: 38 Recruitment Status: TERMINATED Condition: Chronic Myeloid Leukemia
NCTID: NCT02499614
Title: Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS) Study Summary: Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification or MET exon 14 mutation Sponsor: Fondazione Ricerca Traslazionale Intervention: Crizotinib Start Date: 2014-12 Last Updated: 2017-10-25 Number of Patients: 80 Recruitment Status: UNKNOWN Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT03823625
Title: An Open-label, Randomized, Parallel, Non Comparative, Phase II Trial of Nivolumab Plus Ipilimumab Versus Platinum-based Chemotherapy Plus Nivolumab in Chemonaive Metastatic or Recurrent Squamous-Cell Lung Cancer (SqLC) Study Summary: Non-small-cell Lung Cancer (NSCLC) remains the leading cause of cancer death in Western Countries. Approximately 85% of lung cancers are of the non-small-cell type (NSCLC), with 25-30% of NSCLC being squamous histology type. Unlike nonsquamous NSCLC, squamous NSCLC rarely harbors epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations for which there are directed therapies, and until the recent approval of immunotherapies for pretreated squamous NSCLC, a limited number of traditional cytotoxic chemotherapy drugs have been FDA-approved for use in the treatment of advanced and metastatic squamous NSCLC. A platinum-based combination chemotherapy regimen has been the standard first-line treatment for all NSCLC. Carboplatin is frequently substituted for cisplatin for patients who have poor renal function or who experience toxicities from cisplatin (most notably, nausea and vomiting). Taxanes, especially paclitaxel, or vinorelbine or gemcitabine, commonly complete the standard two-drug backbone of platinum-based chemotherapy for the first-line treatment of NSCLC, with platin-gemcitabine as the most commonly used regimen in Europe in patients with squamous-histology. A recent press release announced that pembrolizumab plus chemotherapy produced higher response rate when compared to chemotherapy alone in patients with squamous-cell lung cancer. Nevertheless, no data on Progression-Free Survival (PFS) and Overall Survival (OS) are available. Therefore, considering the lack of data in patients with squamous histology and the lack of information about efficacy of combinations of immune-checkpoints inhibitors versus immune-checkpoint inhibitor plus chemotherapy, there is a strong rationale for conducting a study assessing efficacy of such strategies in patients with advanced, metastatic squamous-cell lung cancer. Sponsor: Fondazione Ricerca Traslazionale Intervention: Nivolumab plus Ipilimumab Start Date: 2017-09-13 Last Updated: 2020-03-25 Number of Patients: 112 Recruitment Status: UNKNOWN Condition: Squamous-Cell Lung Cancer
NCTID: NCT01754285
Title: Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea Study Summary: This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection. Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg. Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows: Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites. Sponsor: Chemi S.p.A. Intervention: LF-PB and Placebo Start Date: 2012-11 Last Updated: 2014-07-29 Number of Patients: 114 Recruitment Status: COMPLETED Condition: Lymphorrhea
NCTID: NCT02576431
Title: A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors Study Summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. Sponsor: Bayer Intervention: BAY2757556 (Larotrectinib, Vitrakvi) Start Date: 2015-09-30 Last Updated: 2023-11-07 Number of Patients: 204 Recruitment Status: RECRUITING Condition: Solid Tumors Harboring NTRK Fusion
NCTID: NCT02388048
Title: Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia Study Summary: A clinical study to evaluate a treatment with two drugs, named Ofatumumab and Ibrutinib, in patients with lymphoblastic acute leukemia who have been already treated with other therapies. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Ibrutinib + ofatumumab Start Date: 2015-10 Last Updated: 2021-09-08 Number of Patients: 19 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Leukemia, Lymphoblastic, Chronic
NCTID: NCT03493451
Title: Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Study Summary: This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: * Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) * Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) * Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant). Sponsor: BeiGene Intervention: Tislelizumab Start Date: 2018-04-13 Last Updated: 2022-05-04 Number of Patients: 77 Recruitment Status: COMPLETED Condition: Peripheral T Cell Lymphoma
NCTID: NCT03016312
Title: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen Study Summary: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 <math display="block">anti-PD-L1</math> antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-01-10 Last Updated: 2023-02-17 Number of Patients: 772 Recruitment Status: COMPLETED Condition: Prostatic Neoplasms, Castration-Resistant
NCTID: NCT02602314
Title: Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia Study Summary: The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Imatinib Start Date: 2016-11-11 Last Updated: 2022-01-20 Number of Patients: 450 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Chronyc Myeloid Leukemia
NCTID: NCT01656551
Title: MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer Study Summary: The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC. Sponsor: National Cancer Institute, Naples Intervention: Gemcitabine Start Date: 2012-08 Last Updated: 2023-03-24 Number of Patients: 232 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Non-small Cell Lung Cancer Metastatic
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: NCT02244021
Title: BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in R/R HL Patients Non Responding to IGEV Study Summary: A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin’s lymphoma patients non-responding to IGEV salvage treatment. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: BRENTUXIMAB VEDOTIN Start Date: 2014-12 Last Updated: 2018-02-09 Number of Patients: 13 Recruitment Status: COMPLETED Condition: Relapsed/Refractory Hodgkin’s Lymphoma
NCTID: NCT04400942
Title: Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy Study Summary: The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram. This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy. Sponsor: Ospedale Policlinico San Martino Intervention: Transvaginal ultrasound Start Date: 2015-01-01 Last Updated: 2021-03-04 Number of Patients: 600 Recruitment Status: UNKNOWN Condition: Uterine Fibroids
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: NCT02536300
Title: Dose Optimization Study of Idelalisib in Follicular Lymphoma Study Summary: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options. Sponsor: Gilead Sciences Intervention: Idelalisib Start Date: 2016-01-14 Last Updated: 2023-08-14 Number of Patients: 96 Recruitment Status: TERMINATED Condition: Follicular Lymphoma
NCTID: NCT04662255
Title: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Study Summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress. Sponsor: Loxo Oncology, Inc. Intervention: Pirtobrutinib Start Date: 2021-04-08 Last Updated: 2023-10-04 Number of Patients: 500 Recruitment Status: RECRUITING Condition: Lymphoma, Mantle-Cell
NCTID: 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: NCT01568866
Title: Phase 3 Study With Carfilzomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed Multiple Myeloma Patients Study Summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone. Sponsor: Amgen Intervention: Carfilzomib Start Date: 2012-06-20 Last Updated: 2022-11-14 Number of Patients: 929 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT02371161
Title: Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy Study Summary: A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: R-DHAP/R-ICE Start Date: 2014-02 Last Updated: 2018-04-25 Number of Patients: 135 Recruitment Status: UNKNOWN Condition: Non Hodgkin Lymphoma
NCTID: NCT02668653
Title: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Study Summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. Sponsor: Daiichi Sankyo, Inc. Intervention: Chemotherapy Start Date: 2016-09-01 Last Updated: 2023-11-18 Number of Patients: 539 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: 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: NCT03542461
Title: Early Switch Maintenance vs Delayed Second-line Nivolumab in Advanced Stage Squamous Non-small Cell Lung Cancer (NSCLC) Patients (EDEN Trial) Study Summary: The study’s hypothesis is that using Nivolumab as early switch maintenance, after 4-6 cycles of standard first-line chemotherapy, might improve survival in patients with advanced stage squamous NSCLC. Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica Intervention: Nivolumab 10 MG/ML Intravenous Solution Start Date: 2017-09-25 Last Updated: 2022-10-03 Number of Patients: 125 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Squamous Non-small Cell Lung Cancer
NCTID: NCT04790253
Title: PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study) Study Summary: In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population. Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Intervention: Prophylactic cranial irradiation Start Date: 2022-10-27 Last Updated: 2023-11-03 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Limited Stage Small Cell Lung Cancer
NCTID: NCT03486873
Title: Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Study Summary: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Sponsor: Merck Sharp & Dohme LLC Intervention: Pembrolizumab Start Date: 2018-08-21 Last Updated: 2023-11-27 Number of Patients: 2300 Recruitment Status: RECRUITING Condition: Solid Tumors
NCTID: NCT03891238
Title: Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin. The ARIES Study Study Summary: This is a single arm, open label, phase II study to evaluate the activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced urothelial cancer considered unfit to cisplatin-based chemotherapy, to be conducted in conformance with Good Clinical Practices. Cisplatin-unfit patients will be defined if at least one of these characteristics is present: # ECOG-Performance status = 2; # Creatinine Clearance < 60 ml/min; # Grade 2 or worse peripheral neuropathy or hearing loss; # Previous treatment with cisplatin for adjuvant intent in six months before the progression of disease. Sponsor: Consorzio Oncotech Intervention: Avelumab Start Date: 2019-02-06 Last Updated: 2019-03-26 Number of Patients: 67 Recruitment Status: UNKNOWN Condition: Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer
NCTID: NCT02668588
Title: Extended-release of Octreotide (LF-PB) for the Treatment of Seroma Study Summary: This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND). Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo. Sponsor: Chemi S.p.A. Intervention: extended release of octreotide Start Date: 2015-10-22 Last Updated: 2017-02-02 Number of Patients: 48 Recruitment Status: COMPLETED Condition: Seroma
NCTID: NCT02513394
Title: PALbociclib CoLlaborative Adjuvant Study Study Summary: This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned. Sponsor: Alliance Foundation Trials, LLC. Intervention: Palbociclib Start Date: 2015-08 Last Updated: 2023-06-15 Number of Patients: 5796 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05352672
Title: Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma Study Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: * To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) * To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab * To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component * To assess immunogenicity of fianlimab and cemiplimab * To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults * To characterize safety and tolerability of treatment in patients 12 to <18 years of age * To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age * To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab * To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years Sponsor: Regeneron Pharmaceuticals Intervention: Fianlimab Start Date: 2022-07-14 Last Updated: 2023-11-24 Number of Patients: 1590 Recruitment Status: RECRUITING Condition: Melanoma
NCTID: NCT05015010
Title: Alectinib in Neo-adjuvant Treatment of Stage III NSCLC Study Summary: Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most effective treatment approach needs a multidisciplinary approach. In this trial we want to test in ALK positive stage III locally advanced NSCLC patients, the efficacy of Alectinib to induce tumor shrinkage when administered before surgery and to reduce the possibility of disease recurrence, with a limited risk of toxicity related, in long term administration after surgery. Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica Intervention: Alectinib Start Date: 2021-05-20 Last Updated: 2022-10-03 Number of Patients: 33 Recruitment Status: RECRUITING Condition: Non Small Cell Lung Cancer
NCTID: NCT01951430
Title: Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients Study Summary: The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Antibiotic and antifungal drugs Start Date: 2014-03 Last Updated: 2021-09-13 Number of Patients: 229 Recruitment Status: COMPLETED Condition: Myelodysplastic Syndrome
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: 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: NCT02312258
Title: A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) Study Summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major 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 initial therapy and who have not undergone SCT. Sponsor: Takeda Intervention: Placebo Start Date: 2015-04-09 Last Updated: 2023-09-21 Number of Patients: 706 Recruitment Status: COMPLETED Condition: Multiple Myeloma
NCTID: NCT02926196
Title: Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab Study Summary: Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy. Sponsor: Istituto Oncologico Veneto IRCCS Intervention: MSB0010718C Start Date: 2016-06-17 Last Updated: 2023-10-31 Number of Patients: 474 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Triple Negative Breast Neoplasms
NCTID: NCT04471428
Title: Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy Study Summary: This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab given in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC, with no sensitizing EGFR mutation or ALK translocation, who have progressed following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially. Sponsor: Hoffmann-La Roche Intervention: Cabozantinib Start Date: 2020-10-01 Last Updated: 2023-05-31 Number of Patients: 366 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Carcinoma, Non-Small-Cell Lung
NCTID: NCT01910623
Title: Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia Study Summary: This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life. The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these in patients’ life. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Health Related Quality of Life (HRQOL) measures Start Date: 2013-02 Last Updated: 2014-10-02 Number of Patients: NA Recruitment Status: COMPLETED Condition: Acute Promyelocytic Leukemia
NCTID: NCT02918084
Title: CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer Study Summary: Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet. Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy Intervention: Anastrozole or Letrozole or Exemestane Start Date: 2013-06 Last Updated: 2022-05-24 Number of Patients: 1000 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Breast Cancer
NCTID: NCT05498428
Title: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer Study Summary: The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation <math display="block">SC-CF</math>) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Sponsor: Janssen Research & Development, LLC Intervention: Amivantamab Start Date: 2022-11-11 Last Updated: 2023-11-18 Number of Patients: 390 Recruitment Status: RECRUITING Condition: Carcinoma, Non-small-Cell Lung
NCTID: NCT05382741
Title: Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial Study Summary: The purpose of this study is to evaluate the efficacy of Durvalumab plus Regorafenib versus observation for patients with stage IV colorectal cancer achieving the no evidence of disease state. The NED state can be achieved in any line of treatment and it is defined as: # R0 resection for surgery, # the complete ablation defect covering the lesion on CT scan for radiofrequency, # the erogation of ≥ 60 Gy for stereotactic radiotherapy, # complete response to antineoplastic treatments on CT scan. In all these cases CEA and CA 19.9 must be within normal limits at the time of randomization. Participants in this study will receive: Experimental arm: Regorafenib 90 mg d1-21 every 28 days plus Durvalumab 1500 mg every 28 days for 1 year Control arm: Observation (crossover to Experimental arm is allowed in case of relapse) Tumor assessment will be performed every 12 weeks. Sponsor: Ospedale Policlinico San Martino Intervention: Durvalumab Injection for intravenous use 500 mg vial solution for infusion Start Date: 2022-03-02 Last Updated: 2023-05-17 Number of Patients: 182 Recruitment Status: RECRUITING Condition: Colorectal Cancer Stage IV
NCTID: NCT03148418
Title: A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A) Study Summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first. Sponsor: Hoffmann-La Roche Intervention: Atezolizumab Start Date: 2017-09-20 Last Updated: 2023-11-18 Number of Patients: 382 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Cancer
NCTID: NCT05909410
Title: Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome Study Summary: Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population. This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS. Sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia Intervention: Survey investigating the CHC use and patients’ perception about the relationship between CHC and cancer, diseases and symptoms Start Date: 2023-07-01 Last Updated: 2023-06-18 Number of Patients: 180 Recruitment Status: NOT_YET_RECRUITING Condition: Lynch Syndrome
NCTID: NCT01358084
Title: Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced MPM Study Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma Sponsor: AGC Biologics S.p.A. Intervention: NGR-hTNF Start Date: 2011-03 Last Updated: 2019-01-15 Number of Patients: 137 Recruitment Status: COMPLETED Condition: Advanced Malignant Pleural Mesothelioma
NCTID: NCT03379441
Title: Pembrolizumab (MK-3475) as Maintainance in Treated Patients With Unresectable Stage III NSCLC Study Summary: Maintainance therapy in patients with unresectable stage III, NSCLC Stage IIIA-B, unresectable, NSCLC, treated with definitive Chemo-Radiotherapy Sponsor: University of Turin, Italy Intervention: Pembrolizumab Injectable Product Start Date: 2018-01-01 Last Updated: 2017-12-22 Number of Patients: 126 Recruitment Status: UNKNOWN Condition: Non Small Cell Lung Cancer Patients
NCTID: NCT02603432
Title: A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) Study Summary: The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy. Sponsor: Pfizer Intervention: Avelumab Start Date: 2016-04-25 Last Updated: 2023-06-06 Number of Patients: 700 Recruitment Status: COMPLETED Condition: Urothelial Cancer
NCTID: NCT05300464
Title: A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection Study Summary: This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram ‘MammoWave’ to detect breast lesions. MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave. The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times. Sponsor: Umbria Bioengineering Technologies Intervention: Clinical investigation medical device class IIa marked CE Start Date: 2023-01-07 Last Updated: 2023-05-09 Number of Patients: 600 Recruitment Status: RECRUITING Condition: Breast Cancer
NCTID: NCT01405573
Title: Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma Study Summary: The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B). Sponsor: National Cancer Institute, Naples Intervention: Best Supportive Care Start Date: 2011-07 Last Updated: 2017-03-28 Number of Patients: 35 Recruitment Status: TERMINATED Condition: Advanced Adult Hepatocellular Carcinoma
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: NCT04603495
Title: Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Study Summary: A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Sponsor: Constellation Pharmaceuticals Intervention: Pelabresib Start Date: 2020-11-19 Last Updated: 2023-09-25 Number of Patients: 431 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Myelofibrosis
NCTID: NCT01980498
Title: PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy Study Summary: The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy. Sponsor: L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. Intervention: Fentanyl pectin nasal spray (FPNS) Start Date: 2014-09 Last Updated: 2015-10-07 Number of Patients: 0 Recruitment Status: WITHDRAWN Condition: Predictable BTP at Swallowing in in Head
eck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain NCTID: NCT04508140
Title: Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis Study Summary: This is an open, single arm, multicenter phase 2 trial in which BO-112 will be administered intratumorally in combination with intravenous pembrolizumab in patients with liver metastasis from colorectal, gastric or gastroesophageal junction cancers. The objective is to reverse the primary resistance that a subgroup of patients from these tumors having microsatellite stability present to the PD-1 inhibitors. Treatment will be administered every 3 weeks, with the exception of the first cycle, in which BO-112 will be also administered on D8, for up to 2 years. The primary objective is overall response rate based on RECIST 1.1 and safety, specifically referred to treatment emergent adverse events (TEAEs) with severity ≥ Grade 3 related to the study treatment (NCI-CTCAE v 5.0). The secondary endpoints include other efficacy endpoints (duration of response, disease control rate, progression-free survival, overall survival at 6 months, all based on RECIST 1.1, and overall response rate based on a specific tumor assessment criteria to evaluate the response to immunotherapies, IRECIST) and safety, in this case considering the number and proportion of subjects with treatment TEAEs (any grade) . In addition, the changes in the tumor microenvironment induced by the injection of BO-112 will be also evaluated as exploratory endpoints. Sponsor: Highlight Therapeutics Intervention: Hepatic Biopsy Start Date: 2020-06-17 Last Updated: 2022-12-13 Number of Patients: 18 Recruitment Status: TERMINATED Condition: Colorectal Cancer
NCTID: NCT04259944
Title: Post-surgical Liquid Biopsy-guided Treatment of Stage III and High-risk Stage II Colon Cancer Patients: the PEGASUS Trial Study Summary: PEGASUS is a prospective multi-centric study designed to prove the feasibility of using liquid biopsy to guide the post-surgical and post-adjuvant clinical management in 140 microsatellite stable Stage-III and T4N0 Stage-II colon cancer patients. Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology Intervention: CAPOX Start Date: 2020-06-16 Last Updated: 2023-09-28 Number of Patients: 140 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colon Cancer
NCTID: NCT05270044
Title: Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. Study Summary: The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). Sponsor: Pierre Fabre Medicament Intervention: Encorafenib and Binimetinib Start Date: 2022-05-02 Last Updated: 2023-11-22 Number of Patients: 815 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Melanoma
NCTID: NCT05483374
Title: The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers Study Summary: Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care. The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook). The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients’ and cancers’ variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes. Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients’ personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU. Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Intervention: observation Start Date: 2022-05-31 Last Updated: 2022-08-02 Number of Patients: 13600 Recruitment Status: RECRUITING Condition: Head and Neck Cancer
NCTID: NCT03567876
Title: Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL Study Summary: Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival. Sponsor: Fondazione Italiana Linfomi - ETS Intervention: Venetoclax Start Date: 2018-09-03 Last Updated: 2023-09-13 Number of Patients: 141 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Lymphoma, Mantle-Cell
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: NCT01191957
Title: Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML Study Summary: The purpose of this prospective phase III, open-label, randomized multicenter study is to evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR) undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity conditioning regimen (I.V. BuFlu) as compared to the conventional I.V. BuCy2 program will experience: # A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells Transplant (HSCT) # A similar anti-leukemic activity and a similar or better safety profile, in terms of: #* Early and/or late graft rejection #* Hematopoietic and immunologic recovery #* Chimerism #* Toxicity and incidence of Veno-occlusive Disease (VOD) #* Acute (aGvHD) and chronic graft-versus-host disease (cGvHD) #* Cumulative incidence of TRM at +100 days and 2 years after transplant #* Cumulative incidence of relapse by 1 and 2 years after transplant #* Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: Busulphan plus Cyclophosphamide Start Date: 2008-01 Last Updated: 2023-03-10 Number of Patients: 252 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia (AML)
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: NCT03230734
Title: Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer Study Summary: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: * Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) * Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease). Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori Intervention: Radium-223 Start Date: 2017-09-01 Last Updated: 2023-05-30 Number of Patients: 70 Recruitment Status: RECRUITING Condition: Metastatic Castration-resistant Prostate Cancer
NCTID: NCT00375674
Title: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer Study Summary: To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery. Sponsor: Pfizer Intervention: Sunitinib malate Start Date: 2007-08-01 Last Updated: 2018-09-21 Number of Patients: 674 Recruitment Status: COMPLETED Condition: Kidney Neoplasms
NCTID: NCT05198934
Title: Sotorasib and Panitumumab Versus Investigator’s Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation Study Summary: The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator’s choice (trifluridine and tipiracil, or regorafenib). Sponsor: Amgen Intervention: Sotorasib Start Date: 2022-04-19 Last Updated: 2023-09-21 Number of Patients: 160 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Colorectal Cancer (CRC)
NCTID: NCT05907057
Title: An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. Study Summary: The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive <math display="block">IDH1m</math>) and cannot receive treatment with intensive chemotherapy (IC). Sponsor: Servier Affaires Médicales Intervention: Ivosidenib 500mg Oral Tablet Start Date: 2023-06-14 Last Updated: 2023-11-18 Number of Patients: 245 Recruitment Status: RECRUITING Condition: Acute Myeloid Leukemia (AML)
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: NCT04811001
Title: Best EGFR-TKI Sequence in NSCLC Harboring EGFR Mutations Study Summary: The best drug sequencing of dacomitinib or osimertinib in patients with advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation positive non-small-cell lung cancer (NSCLC) has not yet been determined. The study enables investigation of the efficacy of dacomitinib followed by or subsequent to osimertinib osimertinib in patients with classical or uncommon activating EGFR mutations. Efficacy of dacomitinib will be defined in patients with asymptomatic or controlled brain metastases, special population eligible in this clinical trial. Sponsor: Fondazione Ricerca Traslazionale Intervention: Osimertinib Start Date: 2020-06-12 Last Updated: 2023-02-21 Number of Patients: 170 Recruitment Status: RECRUITING Condition: NSCLC
NCTID: NCT01064557
Title: “AIDA” Protocol (LAP 0493) Study Summary: The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: all-trans retinoic acid (ATRA) Start Date: 1993-10 Last Updated: 2020-10-14 Number of Patients: 1068 Recruitment Status: UNKNOWN Condition: Leukemia
NCTID: NCT04476199
Title: Venetoclax and Decitabine Assessment in Patients (≥60 - <75 Years) With Newly Diagnosed AML Eligible for Allo-SCT Study Summary: This trial is a no profit, prospective, phase II, multicentre, non-randomised, uncontrolled, single group assignment, open label study to evaluate the safety and efficacy of the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) as “bridge” to allo-SCT in elderly (≥ 60 - < 75 years) AML patients. The primary objective is to evaluate the proportion of elderly (≥60 - <75 years) patients with newly diagnosed AML, eligible for allo-SCT, treated with the “chemo-free” combination Venetoclax plus Decitabine (VEN-DEC) who get allo-SCT in CR/Cri/MLFS. Sponsor: Gruppo Italiano Trapianto di Midollo Osseo Intervention: Venetoclax and Decitabine Start Date: 2019-12-09 Last Updated: 2023-03-10 Number of Patients: 100 Recruitment Status: COMPLETED Condition: Acute Myeloid Leukemia
NCTID: NCT03367299
Title: Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia Study Summary: The present study aims at analyzing the response to treatment of adult patients homogeneously treated with supportive care, chemotherapy and blinatumomab. Sponsor: Gruppo Italiano Malattie EMatologiche dell’Adulto Intervention: Chemotherapy + Blinatumomab Start Date: 2018-06-08 Last Updated: 2022-01-04 Number of Patients: 149 Recruitment Status: ACTIVE_NOT_RECRUITING Condition: Acute Lymphoid Leukemia
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
