A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Inclusion Criteria: * Documented Diagnosis of previously untreated de novo AML according to WHO 2016 criteria * Presence of a FLT3 mutation status as measured/confirmed by a designated lab with results available prior first dose of Midostaurin * Patients with Lansky or Karnofsky performance status equal or superior to 60 * Patient with the following laboratory value : AST and ALT ≤ 3times ULN * Serum Total bilirubin ≤ 1.5times ULN * Estimated creatinine clearance ≥30ml/min Exclusion Criteria: * Any concurrent malignancy, AML with Philadelphia Chromosome, AML-DS, JMML * Symptomatic leukemic CNS involvement * Isolated extramedullary leukemia, secondary AML and MDS * Acute Promyelocytic Leukemia with the PML RARA rearrangement * Patient who have received prior treatment with a FLT3 inhibitor. However, up to 1 week of FLT3 inhibitor (except midostaurin) exposure prior to study enrollment is permissible. Other protocol-defined inclusion/exclusion criteria may apply