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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 Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Trial Profile

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 Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2024

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At a glance

  • Drugs Enasidenib (Primary) ; Ivosidenib (Primary) ; Antineoplastics; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms AMLSG 29-18; HOVON 150 AML

Most Recent Events

  • 02 Oct 2024 Planned End Date changed from 17 Sep 2034 to 19 Sep 2034.
  • 20 Sep 2024 Planned End Date changed from 1 May 2034 to 17 Sep 2034.
  • 20 Sep 2024 Planned primary completion date changed from 1 Oct 2024 to 17 Apr 2027.

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