Spots Global Cancer Trial Database for A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

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Trial Identification

Brief Title: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Official Title: A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Study ID: NCT06284486

Conditions

Acute Myeloid Leukemia

Interventions

Venetoclax

Revumenib

Study Description

Brief Summary: To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.

Detailed Description: Primary Objectives * Phase I: To determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of revumenib and venetoclax for patients with acute myeloid leukemia (AML) and detectable minimal or measurable residual disease (MRD). * Phase II: To assess the efficacy of the combination of venetoclax and revumenib in clearance of MRD in patients with AML. Secondary Objectives * To assess overall survival (OS), relapse-free survival (RFS), event-free survival (EFS) and duration of response (DOR). * To determine clinical flow and genetic MRD concordance rate Exploratory Objectives * To evaluate molecular and cellular markers that may be predictive of antitumor activity and/or resistance. * To correlate MRD negativity with clinical outcomes (survival and relapse risk) * To evaluate concordance of standard and novel MRD assays * To explore the safety and activity of venetoclax plus revumenib in the pediatric population