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)

Trial Profile

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2017

At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms RATIFY
  • Sponsors Novartis
  • Most Recent Events

    • 20 Sep 2017 According to a Novartis media release, based on the data from this trial the European Commission approved Rydapt for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia with FLT3 mutation-positive. The approval applies to all 28 EU member states, Iceland, Liechtenstein and Norway.
    • 03 Aug 2017 Primary endpoint (Overall Survival (OS)) has been met as per the results published in the New England Journal of Medicine
    • 03 Aug 2017 Results (data cut off March 7, 2016) published in the New England Journal of Medicine
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