NCT06229912

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.

Detailed description

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.

Conditions

• Leukemia
• HOX Gene

Interventions

Type	Name	Description
DRUG	Revumenib	Given by PO

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-01-29
• Last updated: 2026-02-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study