A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study in Asia and Russia to Evaluate the Efficacy and Safety of Twice Daily Oral Midostaurin in Combination With Daunorubicin/Cytarabine Induction, High-dose Cytarabine Consolidation, and Midostaurin Single Agent Continuation Therapy in Newly Diagnosed Patients With FLT3-mutated Acute Myeloid Leukemia (AML).
Phase of Trial: Phase II
Latest Information Update: 06 Mar 2018
At a glance
- Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; Therapeutic Use
- Sponsors Novartis Pharmaceuticals
- 28 Feb 2018 Planned End Date changed from 22 Mar 2022 to 25 Dec 2019.
- 28 Feb 2018 Planned primary completion date changed from 22 Mar 2022 to 11 Apr 2019.
- 27 Feb 2018 Status changed from not yet recruiting to recruiting.