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: 18 Nov 2018
At a glance
- Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; Therapeutic Use
- Sponsors Novartis; Novartis Pharmaceuticals
- 27 Sep 2018 Planned End Date changed from 20 Jul 2022 to 20 Jun 2022.
- 06 Apr 2018 Planned End Date changed from 25 Dec 2019 to 20 Jul 2022.
- 28 Feb 2018 Planned End Date changed from 22 Mar 2022 to 25 Dec 2019.