A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)

The purpose of this study is to compare the effects, good and/or bad, of a standard
chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined
with or without midostaurin (also known as PKC412), to find out which is better. This
research is being done because it is unknown whether the addition of midostaurin to
chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been
tested in over 400 patients and is being studied in a number of illnesses, including AML,
colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as
FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells
will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells
with the abnormal FLT3 gene.