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A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy

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Trial Profile

A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2025

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Ivosidenib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Registrational
  • Sponsors Servier

Most Recent Events

  • 09 Dec 2023 According to Servier media release, data from the study were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition.
  • 13 Jul 2023 Status changed from not yet recruiting to recruiting.
  • 20 Jun 2023 New trial record

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