Leukemia Clinical Trial
Official title:
A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
To learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression 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. ;
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