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: 21 Jul 2017

At a glance

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

    • 21 Jul 2017 According to a Novartis media release, Rydapt received Swissmedic approval on May 4, 2017, and in July 2017, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.
    • 25 Jun 2017 Results assessing FLT3mut status at the time of diagnosis, refractory disease and relapse in acute myeloid leukemia patients treated within the CALGB 10603 (RATIFY, NCT00651261) and AMLSG 16-10 (NCT01477606) trial presented at the 22nd Congress of the European Haematology Association
    • 25 Jun 2017 Results assessing clone evolution of Flt3-Itd positive acute myeloid leukemia at diagnosis and relapse in patients treated within the Calgb 10603 (Ratify, NCT00651261) and Amlsg 16-10 (NCT01477606) trials presented at the 22nd Congress of the European Haematology Association
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top