A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes

Primary Objectives • To assess the efficacy of revumenib in leukemias associated with upregulation of HOX genes. Secondary Objectives * To assess rates of measurable residual disease (MRD) clearance, as assessed by multiparameter flow cytometry in participants who respond to treatment. * To assess rates of cytogenetic remissions in participants with baseline cytogenetic abnormalities at diagnosis. * To assess event-free survival (EFS), duration of response (DOR), and overall survival (OS) in participants with leukemia associated with upregulation of HOX following treatment with revumenib. Exploratory Objectives * To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance * To evaluate HOX/MEIS1 expression as a biomarker of response. * To assess the rate of mutations in the MEN1 gene as a mechanism of resistance.