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).

Trial Profile

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).

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Sep 2017

At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 17 Sep 2017 Planned End Date changed from 13 Jan 2019 to 16 Sep 2020.
    • 17 Sep 2017 Planned primary completion date changed from 13 Jan 2019 to 26 Sep 2020.
    • 17 Sep 2017 Planned initiation date changed from 9 Oct 2017 to 29 Nov 2017.
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