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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)

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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)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin; Idarubicin
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 05 Dec 2019 This trial has been Discontinued in Hungary, according to European Clinical Trials Database.
    • 12 Nov 2019 This trial has been suspended in Bulgaria, according to European Clinical Trials Database record.
    • 11 Oct 2019 Status changed to recruiting.
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