AAML1831: 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

This is a Phase 3 trial that will compare the efficacy of CPX-351 (a combination of 2 standard chemotherapy medicines - Daunorubicin and Cytarabine) compared to standard chemotherapy in the treatment of Acute Myelogenous Leukemia (AML). Patients will be randomly assigned by a computer to receive treatment with either CPX-351 treatment regimen or the standard chemotherapy regimen. In addition, if testing shows that a patient's AML has a specific gene change (FLT3), then those patients will be offered treatment with a new medicine (Gilteritinib) that targets the FLT3 gene change. For all patients who meet High risk criteria, they will be offered bone marrow transplant.

Are you Eligible? (Inclusion Criteria)

• Patient must be less than 22 years of age at the time of study enrollment.
• Patient must have be newly diagnosed with de novo AML.
• Patient must have one of the following: a. Greater than or equal to 20% bone marrow blasts b. Less than 20% bone marrow blast with a qualifying genetic abnormality c. A complete blood count (CBC) of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed
• Patient must also meet all eligibility criteria as outlined in the study protocol.