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
Phase of Trial: Phase II/III
Latest Information Update: 06 Dec 2017
At a glance
- Drugs Gilteritinib (Primary) ; Azacitidine; Azacitidine
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors Astellas Pharma; Astellas Pharma Global Development
- 10 Aug 2017 Planned End Date changed from 14 Oct 2020 to 1 Oct 2020.
- 10 Aug 2017 Planned primary completion date changed from 13 May 2020 to 1 May 2020.
- 06 Jun 2017 Trial design of the study presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.