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A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML)

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A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Feb 2025

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At a glance

  • Drugs Midostaurin (Primary) ; Corticosteroid; Cytarabine; Daunorubicin; Dexamethasone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CALGB10603 / CPKC412A2301; RATIFY
  • Sponsors Novartis; Novartis Pharma A.G.

    • Most Recent Events

    • 19 Dec 2022 This trial has been completed in Italy according to European Clinical Trials Database record.
    • 18 Oct 2022 This trial has been completed in Netherlands (End Date: 26 March 2022) according to European Clinical Trials Database record.
    • 01 Jul 2022 Results of post-hoc analysis assessing effects of strong CYP3A4 inhibitor use on the exposure and safety of midostaurin, published in the Cancer Chemotherapy and Pharmacology.

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