Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Hypomethylating Agent

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    31 result(s) found for: Hypomethylating Agent. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-000327-10 Sponsor Protocol Number: SAMBA Start Date*: 2016-11-03
    Sponsor Name:GWT-TUD GmbH
    Full Title: SINGLE AGENT JNJ-56022473 IN MDS AND AML PATIENTS FAILING HYPOMETHYLATING AGENT BASED THERAPY
    Medical condition: AML and MDS patients failing or being refractory to hypomethylating agent (HMA) treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012984 10000886 Acute myeloid leukemia LLT
    20.0 100000074219 10067096 5q minus myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005257-12 Sponsor Protocol Number: SGI-110-07 Start Date*: 2017-03-17
    Sponsor Name:Astex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Prev...
    Medical condition: Myelodysplastic syndromes (MDS) Chronic myelomonocytic leukemia (CMML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10028536 Myelodysplastic syndromes HLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009018 Chronic myelomonocytic leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) PL (Completed) DK (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001588-22 Sponsor Protocol Number: AML003 Start Date*: 2019-07-04
    Sponsor Name:Rafael Pharmaceuticals, Inc.
    Full Title: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mi...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Prematurely Ended) AT (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001051-32 Sponsor Protocol Number: 2102-HEM-101 Start Date*: 2019-03-14
    Sponsor Name:Forma Therapeutics, Inc.
    Full Title: A Phase 1/2, Multicenter, Open-label Study of FT 2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an...
    Medical condition: Relapsed/refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060558 Acute myeloid leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002675-29 Sponsor Protocol Number: CC-486-MDS-006 Start Date*: 2015-06-19
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 2, International, Multicenter, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of CC-486 (oral azacitidine) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve a...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) BE (Completed) ES (Ongoing) DE (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003111-10 Sponsor Protocol Number: D-00272-CT2014002 Start Date*: 2016-06-01
    Sponsor Name:Cell Medica Ltd
    Full Title: A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) who have failed to achieve...
    Medical condition: Acute myeloid leukaemia and myelodysplastic syndromes in adults
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003353-16 Sponsor Protocol Number: GS-US-339-1559 Start Date*: 2017-04-18
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Patients with Acute Myeloid Leukemia (AML)
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003490-41 Sponsor Protocol Number: AML-PG02 Start Date*: 2016-09-09
    Sponsor Name:PROF.BRUNANGELO FALINI,DR.SSA MARIA PAOLA MARTELLI,UNIVERSITA' DI PERUGIA
    Full Title: A PHASE 2A STUDY ON THE CLINICAL ACTIVITY AND SAFETY OF ACTINOMYCIN-D IN PATIENTS WITH NPM1-MUTATED AML AGED =70 YEARS AND/OR UNFIT FOR INTENSIVE CHEMOTHERAPY, EITHER NEWLY DIAGNOSED OR PREVIOUSLY ...
    Medical condition: NPM1-MUTATED AML NEWLY DIAGNOSED OR PREVIOUSLY TREATED WITH HYPOMETHYLATING AGENTS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001600-29 Sponsor Protocol Number: ARO-013 Start Date*: 2018-06-13
    Sponsor Name:Arog Pharmaceuticals, Inc.
    Full Title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Year...
    Medical condition: Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    20.0 100000004864 10060558 Acute myeloid leukemia recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Ongoing) ES (Ongoing) GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000344-42 Sponsor Protocol Number: AG-221-AML-004 Start Date*: 2016-01-21
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects with Late Stage Acute Myeloid Leukemi...
    Medical condition: Treatment of subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase 2 (IDH2) mut...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10060558 Acute myeloid leukemia recurrent LLT
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) DK (Completed) BE (Completed) AT (Completed) CZ (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000813-19 Sponsor Protocol Number: EURE-CART-1 Start Date*: 2019-09-04
    Sponsor Name:MolMed S.p.A.
    Full Title: A Phase I-IIa trial to assess the safety and antitumor activity of autologous CD44v6 CAR T-cells in acute myeloid leukemia and multiple myeloma expressing CD44v6.
    Medical condition: Acute myeloid leukemia and Multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028228 Multiple myeloma LLT
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000744-55 Sponsor Protocol Number: M15-954 Start Date*: 2020-10-21
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Hig...
    Medical condition: Myelodysplastic Syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) FR (Trial now transitioned) DE (Ongoing) CZ (Trial now transitioned) NL (Trial now transitioned) PL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000705-25 Sponsor Protocol Number: AT148002 Start Date*: 2021-08-11
    Sponsor Name:ALX Oncology Inc.
    Full Title: A PHASE 1/2 STUDY OF ALX148 IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH HIGHER RISK MYELODYSPLASTIC SYNDROME (MDS) (ASPEN-02)
    Medical condition: Patients with higher risk myelodysplastic syndrome (MDS) who have not yet been treated for their disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001476-22 Sponsor Protocol Number: 04-30 Start Date*: 2016-02-16
    Sponsor Name:Onconova Therapeutics, Inc.
    Full Title: A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent
    Medical condition: Myelodysplastic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Prematurely Ended) IE (Prematurely Ended) CZ (Prematurely Ended) FR (Prematurely Ended) HR (Completed) PL (Prematurely Ended) SE (Completed) BE (Prematurely Ended) NL (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004148-39 Sponsor Protocol Number: TED15138 Start Date*: Information not available in EudraCT
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: An open-label, first-in-human, dose escalation study of SAR440234 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-ce...
    Medical condition: Leukaemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024288 Leukaemia PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017376-25 Sponsor Protocol Number: MEK111759 Start Date*: 2011-03-15
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Subjects with Relapsed or Ref...
    Medical condition: Relapsed or refractory leukemias
    Disease: Version SOC Term Classification Code Term Level
    12.1 10000880 Acute myeloid leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002324-41 Sponsor Protocol Number: PH2/051 Start Date*: 2006-11-30
    Sponsor Name:Cancer Research UK
    Full Title: A Cancer Research UK Randomised Multicentre Phase II Trial of the DNA-hypomethylating Agent, 5-Aza-2'-deoxycytidine(Decitabine) given intravenously in Combination with Carboplatin, versus Carboplat...
    Medical condition: Progressive, advanced ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    8.1 10033128 Ovarian cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005999-28 Sponsor Protocol Number: GFM-Erlotinib-08 Start Date*: 2010-02-04
    Sponsor Name:Groupe Francophone des Myélodysplasies (GFM)
    Full Title: PHASE I-II TRIAL OF ERLOTINIB IN HIGHER RISK MYELODYSPLASTIC SYNDROME
    Medical condition: HIGH-RISK MYELODYSPLASTIC SYNDROME (MDS)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028533 Myelodysplastic syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003650-23 Sponsor Protocol Number: KKSH178 Start Date*: 2022-07-29
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Fedratinib in Combination with CC-486, a Hypomethylating Agent, in Patients with Accelerated Phase Myelofibrosis
    Medical condition: Myeloproliferative neoplasm in accelerated phase (MPN-AP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077465 Myeloproliferative neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004287-98 Sponsor Protocol Number: TCD17197 Start Date*: 2022-03-16
    Sponsor Name:Sanofi-Aventis Recherche & Developpement
    Full Title: An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R ...
    Medical condition: Relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10003917 B-cell type acute leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10081513 Acute myeloid leukaemia refractory PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 20 02:21:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA