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: 05 Dec 2017

At a glance

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

    • 05 Dec 2017 According to a Novartis Pharmaceuticals media release, Rydapt has been approved to be used with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy for the treatment of adult patients with newly diagnosed FLT3-mutated AML based on the data from this trial.
    • 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
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