NCT06284486

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	Given by PO
DRUG	Revumenib	Given by PO

Timeline

• Start date: 2024-09-23
• Primary completion: 2026-12-30
• Completion: 2028-12-30
• First posted: 2024-02-29
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study