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Clinical trials for Enasidenib

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    6 result(s) found for: Enasidenib. Displaying page 1 of 1.
    EudraCT Number: 2019-001416-30 Sponsor Protocol Number: IDH2-Post-Allo-Trial Start Date*: 2020-06-18
    Sponsor Name:Heinrich-Heine-University Düsseldorf represented by the Coordinating Investigator
    Full Title: IDH2-Post-Allo-Trial: Enasidenib as consolidation or salvage therapy for patients with IDH2 mutated AML or MDS following allogeneic blood stem cell transplantation
    Medical condition: Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or acute myelogenous leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) and with an IDH2 mutat...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10024329 Leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000451-41 Sponsor Protocol Number: HO150 Start Date*: 2019-03-01
    Sponsor Name:HOVON Foundation
    Full Title: A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therap...
    Medical condition: AML or MDS-EB2 with a mutation in either IDH1 or IDH2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) FI (Trial now transitioned) LT (Trial now transitioned) SE (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) IE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) DK (Prematurely Ended)
    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 (Completed)
    Trial results: View results
    EudraCT Number: 2018-001693-25 Sponsor Protocol Number: GFM-IDEALStudy Start Date*: 2018-11-08
    Sponsor Name:Groupe Francophone des Myelodysplasies
    Full Title: A single-arm phase II multicenter study of IDH2 (AG 221) inhibitor in patients with IDH2 mutated myelodysplastic syndrome
    Medical condition: Myelodysplastic syndromes, mutation IDH-2, inhibitor IDH-2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10025309 Haematological and lymphoid tissue therapeutic procedures HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003951-23 Sponsor Protocol Number: AG-221-AML-005 Start Date*: 2016-07-08
    Sponsor Name:Celgene Corporation
    Full Title: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 P...
    Medical condition: Newly diagnosed acute myeloid leukemia (AML) habouring an isocitrate dehydrogenase 1 (IDH1) or an isocitrate dehydrogenase 2 (IDH2) mutation, respectively, who are not candidates to receive intensi...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Completed) ES (Ongoing) NL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000133-40 Sponsor Protocol Number: 2016-2369 Start Date*: 2016-05-25
    Sponsor Name:Gustave Roussy
    Full Title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
    Medical condition: Relapsed or refractory tumors in children
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) IT (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
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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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