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A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study 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)

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A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study 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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2023

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At a glance

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

    • Most Recent Events

    • 23 Feb 2023 Status changed from active, no longer recruiting to completed.
    • 26 Oct 2022 Planned End Date changed from 21 Nov 2022 to 21 Apr 2023.
    • 09 Dec 2021 New source identified and integrated (Japan Pharmaceutical Information Center - Clinical Trials Information record: JapicCTI183915).

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