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A phase 3 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)

To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.

A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

This study has been transitioned to CTIS with ID 2022-502478-18-00 check the CTIS register for the current data. To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year…