SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

PRIMARY OBJECTIVE: I. To determine the safety of revumenib (SNDX-5613) + gilteritinib. SECONDARY OBJECTIVES: I. To determine the preliminary efficacy of SNDX- 5613+ Gilteritinib. EXPLORATORY OBJECTIVES: I. To perform pharmacokinetic and pharmacodynamics assessments of the study drug combination. OUTLINE: This is a dose-escalation study. Patients receive SNDX-5613 orally (PO) twice per day (BID) and gilteritinib PO once per day (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) or multigated acquisition (MUGA) scan during screening, as well as bone marrow biopsy and aspiration and blood sample collection throughout the study. After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 2 years.