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A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

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Trial Profile

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

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

Latest Information Update: 22 Aug 2024

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At a glance

  • Drugs Ivosidenib (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AGILE
  • Sponsors Agios Pharmaceuticals

Most Recent Events

  • 03 Apr 2024 Planned End Date changed from 30 Jun 2024 to 30 Jun 2026.
  • 12 Dec 2023 Results performing an NGS analysis of MRD responses in this study,presented at the 65th American Society of Hematology Annual Meeting and Exposition
  • 05 Dec 2023 According to a Servier media release, data from this trial will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition 2023.

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