100-20 | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Overview

“A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations”

Survival in childhood AML has plateaued despite maximally toxic standard therapy. This study, AAML1831, will evaluate two strategic objectives to improve outcomes and reduce toxicities: 1) continue to build a therapeutic backbone for all patients that improves survival through enhanced efficacy and reduced anthracycline-associated toxicities, 2) introduce target-specific therapies that improve survival without increased toxicity. AAML1831 is a randomized Phase 3 trial that will compare efficacy of CPX-351 (a liposomal preparation of daunorubicin and cytarabine) during Induction 1 and Induction 2 versus standard chemotherapy for children with de novo, non FLT3-mutant AML. This trial incorporates important lessons learned from prior COG Phase 3 studies.