Phase III Study of Venetoclax and Revumenib Combination to Treat Minimal Residual Disease in Acute Myeloid Leukemia

What this Trial Is About

Researchers are investigating whether the combination of venetoclax and revumenib can help control minimal or measurable residual disease MRD in patients with acute myeloid leukemia AML. This Phase III study aims first to determine the safety and best dose of this combination, and then to evaluate how well it clears MRD in AML patients. The study also explores survival outcomes and molecular markers that may predict treatment response or resistance, including in pediatric patients. Participants will receive venetoclax and revumenib together for up to one year, followed by one additional year of venetoclax alone. Venetoclax is taken orally once daily on days 1 to 14 of each treatment cycle, preferably with breakfast and water. If the disease worsens or side effects become intolerable, study drugs will be stopped. The study includes an initial dose-finding phase and a second phase to assess effectiveness. During the study, participants will be closely monitored for safety and side effects over about one year. Researchers will assess the clearance of MRD and measure outcomes such as overall survival and relapse-free survival. Laboratory tests and other assessments will evaluate molecular and genetic markers related to treatment response. Participation may last up to two years including the treatment and follow-up periods.

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