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A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

Trial Profile

A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2019

At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin; Idarubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals
  • Most Recent Events

    • 14 Dec 2018 Planned End Date changed from 20 Apr 2026 to 28 Apr 2026.
    • 31 Aug 2018 Biomarkers information updated
    • 09 Jul 2018 Planned End Date changed from 8 Apr 2026 to 20 Apr 2026.
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