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

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Oct 2017

At a glance

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

    • 19 Jan 2017 Planned End Date changed from 1 Dec 2019 to 1 Dec 2018.
    • 09 Nov 2016 Planned number of patients changed from 131 to 123.
    • 24 Oct 2016 Planned number of patients changed from 272 to 131.
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