Trial Identifiers
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Scientific Title
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)
Commercial Sponsor
Novartis Pharmaceuticals
Summary
This study aims to assess the benefits of using a combination of Midostaurin and chemotherapy to treat Acute Myeloid Leukaemia - FLT3 Mutation Negative. Patients eligible to participate in this study will initially receive midostaurin, or a placebo, twice a day as well as chemotherapy. This will be followed by 12 x 28-day cycles of midostaurin, or placebo, alone.