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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

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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2023

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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

    • 19 Dec 2022 The trial has been discontinued in Denmark, according to European Clinical Trial Registry record.
    • 13 Feb 2022 This trial has been suspended in France, according to European Clinical Trials Database record.
    • 16 Oct 2020 According to an Agios Pharmaceuticals media release, company is advancing two phase 3 combination trials of TIBSOVO in newly diagnosed AML patients, If these trials are positive, company anticipate pursuing approvals in these indications in both the U.S. and EU.
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