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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: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2023

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At a glance

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

    • Most Recent Events

    • 17 Jun 2022 Results assessing the impact of NGS-MRD results on long-term outcomes, presented at the 27th Congress of the European Haematology Association.
    • 14 Dec 2021 Final results and Measurable Residual Disease (MRD) analyses presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 14 Jun 2021 Status changed from active, no longer recruiting to completed.
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