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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 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Trial Profile

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 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 31 Jan 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Enasidenib (Primary) ; Ivosidenib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 07 Mar 2023 Planned End Date changed from 4 Jan 2023 to 31 Oct 2024.
    • 13 Dec 2022 Results (n=101) assessing the association between molecular characteristics and clinical outcomes with enasidenib plus azacitidine and azacitidine only in that trial, presented at the 64th American Society of Hematology Annual Meeting and Exposition.
    • 13 Dec 2022 Results (n=55) of an analysis to determine molecular mechanism of response and therapy resistance using samples from newly diagnosed mIDH2 AML patients presented at the 64th American Society of Hematology Annual Meeting and Exposition
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