A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

Trial Profile

A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Gilteritinib (Primary) ; Azacitidine; Azacitidine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 06 Jun 2017 Trial design of the study presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 13 Feb 2017 Planned End Date changed from 1 Aug 2020 to 1 Oct 2020.
    • 13 Feb 2017 Planned primary completion date changed from 1 Jul 2019 to 1 May 2020.
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