Phase II Study of Revumenib, a Menin Inhibitor, for Treating Leukemia with Increased HOX Gene Activity

What this Trial Is About

Researchers are evaluating revumenib, a drug also known as SNDX-5613, in people with leukemia linked to increased expression of HOX genes. This Phase II study aims to assess how well revumenib works in controlling such leukemias and to understand its effects on measurable residual disease, cytogenetic remission, event-free survival, duration of response, and overall survival. The study also explores molecular markers that might predict response or resistance to treatment. Participants who qualify will take revumenib orally twice daily, about 12 hours apart, during each 28-day treatment cycle. The study focuses on relapsed or refractory acute leukemia of various lineages with specific genetic alterations associated with HOX gene upregulation. The treatment continues in cycles, with ongoing monitoring to assess effectiveness and safety. During the study, participants will be closely monitored for safety and adverse events, with an average follow-up of about one year. Researchers will conduct assessments including blood tests and other evaluations to track response and side effects. Participants or their guardians must provide informed consent, and the study collects data on molecular and cellular markers to understand treatment response better over the course of participation.

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