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Clinical trials for Romidepsin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Romidepsin. Displaying page 1 of 1.
    EudraCT Number: 2015-003186-28 Sponsor Protocol Number: BPC01_002 Start Date*: 2016-01-13
    Sponsor Name:Bionor Pharma ASA
    Full Title: BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an assessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the H...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005023-40 Sponsor Protocol Number: RG_11-182 Start Date*: 2013-05-22
    Sponsor Name:University of Birmingham
    Full Title: ROMAZA: Phase I trial of combination therapy with romidepsin and azacitidine in patients with newly diagnosed, relapsed or refractory Acute Myeloid Leukaemia ineligible for conventional chemotherapy
    Medical condition: Acute myeloid leukaemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-004747-23 Sponsor Protocol Number: BPC01-001 Start Date*: 2014-01-17
    Sponsor Name:Bionor Pharma ASA
    Full Title: An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization using Vacc-4x + rhuGM-CSF, and HIV-1 Reactivation using Romidepsin, on the Viral Reservoir in Virologic...
    Medical condition: HIV-infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10008919 Chronic HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001879-20 Sponsor Protocol Number: RG_13-107 Start Date*: 2013-12-30
    Sponsor Name:University of Birmingham
    Full Title: Phase I/II study to determine the maximum tolerated dose and activity of the combination of romidepsin and carfilzomib in relapsed or refractory peripheral T-cell lymphoma
    Medical condition: Peripheral T-cell Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034626 Peripheral T-cell lymphoma unspecified refractory PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034625 Peripheral T-cell lymphoma unspecified recurrent PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-005238-23 Sponsor Protocol Number: MCA-896 Start Date*: 2016-10-18
    Sponsor Name:Rockefeller University
    Full Title: A phase 2a, randomized study of the combination of romidepsin and 3BNC117 to evaluate the effects on the HIV-1 reservoir (ROADMAP)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10020180 HIV positive LLT
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-023040-32 Sponsor Protocol Number: ROMI-ADVM-004 Start Date*: 2011-05-05
    Sponsor Name:Celgene Corporation
    Full Title: A phase IV, Open-Label, Single-Arm ROLLOVER STUDY FOR SUBJECTS WHO PARTICIPATED IN OTHER ROMIDEPSIN PROTOCOLS. Estudio de extensión de fase IV, abierto, de un solo brazo para pacientes que hayan p...
    Medical condition: Rollover study supporting all indications from prior Romidepsin protocols eligible for participation in this study. Estudio de extensión que recoge todas las indicaciones de protocolos anteriores d...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10001414 Adult T-cell lymphomas/leukaemias HLT
    12.1 10042971 T-cell lymphoma LLT
    12.1 10042979 T-cell lymphoma recurrent LLT
    12.1 10042980 T-cell lymphoma refractory LLT
    12.1 10042981 T-cell lymphoma stage I LLT
    12.1 10042982 T-cell lymphoma stage II LLT
    12.1 10042983 T-cell lymphoma stage III LLT
    12.1 10042984 T-cell lymphoma stage IV LLT
    12.1 10002450 Angioimmunoblastic T-cell lymphomas HLT
    12.1 10022704 Intestinal T-cell lymphomas HLT
    12.1 10034622 Peripheral T-cell lymphomas NEC HLT
    12.1 10042988 T-cell unclassifiable lymphomas HLT
    12.1 10001414 Adult T-cell lymphomas/leukaemias HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-001580-68 Sponsor Protocol Number: Ro-CHOP_study Start Date*: 2013-06-10
    Sponsor Name:LYSARC
    Full Title: Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma.
    Medical condition: Peripheral T-Cell Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10034623 Peripheral T-cell lymphoma unspecified PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Ongoing) IT (Completed) DE (Completed) PT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005179-41 Sponsor Protocol Number: FIL_PTCL13 Start Date*: 2014-05-27
    Sponsor Name:Fondazione Italiana Linfomi ONLUS (FIL-ONLUS)
    Full Title: ROMIDEPSIN IN COMBINATION WITH CHOEP AS FIRST LINE TREATMENT BEFORE HEMATOPOIETIC STEM CELL TRANSPLANTATION IN YOUNG PATIENTS WITH NODAL PERIPHERAL T-CELL LYMPHOMAS: A PHASE I-II STUDY.
    Medical condition: Newly diagnosed patients with Peripheral T-cell lymphomas including: Peripheral T-cell lymphomas not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL) and ALK– Anaplastic la...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-006228-21 Sponsor Protocol Number: GPI-06-0002 Start Date*: 2007-05-10
    Sponsor Name:Gloucester Pharmaceuticals Inc.
    Full Title: A PHASE II, MULTICENTER, OPEN-LABEL TRIAL EVALUATING THE ACTIVITY AND TOLERABILITY OF ROMIDEPSIN (DEPSIPEPTIDE, FK228) IN PROGRESSIVE OR RELAPSED PERIPHERAL T-CELL LYMPHOMA FOLLOWING PRIOR SYSTEM...
    Medical condition: Progressive or relapsed Peripheral T-Cell Lymphoma (PTCL)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10034624 Peripheral T-cell lymphoma unspecified NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) FR (Completed) ES (Completed) SE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005157-23 Sponsor Protocol Number: DART Start Date*: 2013-05-21
    Sponsor Name:Fondazione IRCCS Istituto Nazionale Tumori
    Full Title: A Phase I/II Study of Danusertib in Combination with Romidepsin in Adult Patients with Mature Peripheral T Cell Lymphoma (PTCL)
    Medical condition: (Ph I) Relapsed or refractory Hodgkin (HL) and Non Hodgkin lymphoma (NHL) in patients in the absence, unable ot who have been refused to undergo alternative salvage regimens. (Ph II) Relapsed or r...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10025319 Lymphomas Hodgkin's disease HLGT
    14.1 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    14.1 10005329 - Blood and lymphatic system disorders 10025322 Lymphomas non-Hodgkin's unspecified histology HLGT
    14.1 10005329 - Blood and lymphatic system disorders 10025321 Lymphomas non-Hodgkin's T-cell HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001625-40 Sponsor Protocol Number: AX-CL-PANC-PI-008619 Start Date*: 2019-10-21
    Sponsor Name:GWT-TUD GmbH
    Full Title: A MULTICENTER, PHASE I/II STUDY OF SEQUENTIAL EPIGENETIC AND IMMUNE TARGETING IN COMBINATION WITH NAB-PACLITAXEL/GEMCITABINE IN PATIENTS WITH ADVANCED PANCREATIC DUCTAL ADENOCARCINOMA
    Medical condition: Pancreatic Ductal Adenocarcinoma (PDAC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033604 Pancreatic cancer LLT
    21.1 100000004864 10051971 Pancreatic adenocarcinoma LLT
    21.0 100000004864 10033599 Pancreatic adenocarcinoma metastatic LLT
    21.1 100000004864 10033605 Pancreatic cancer metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002234-53 Sponsor Protocol Number: eCLEAR-001 Start Date*: 2016-11-14
    Sponsor Name:Department of Infectious Diseases, Aarhus University Hospital
    Full Title: Early administration of anti-latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a random...
    Medical condition: HIV persistence during initiation of antiretroviral therapy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10073675 HIV infection CDC category unspecified LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2012-001404-38 Sponsor Protocol Number: FIL_GEMRO Start Date*: 2012-07-12
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: Phase IIa study on the role of Gemcitabine plus Romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients.
    Medical condition: Relapsed/refractory peripheral T-cell lymphoma patients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10025321 Lymphomas non-Hodgkin's T-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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