Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia

This is a prospective, single-arm clinical study evaluating the efficacy and safety of metformin in inhibiting DNMT3A R882-driven clonal hematopoiesis (CH) in patients with acute leukemia (AL) who are in remission and under follow-up. Patients with DNMT3A R882 mutation (VAF ≥5%) will receive oral metformin for 6 months, with dosage gradually increased to 2000 mg/day. The primary endpoint is the proportion of patients with effective decline in DNMT3A R882 mutation VAF at 6 months. Secondary endpoints include VAF decline at 3 months, relapse-free survival (RFS) at 6 and 12 months, overall survival (OS), cumulative incidence of relapse (CIR), cumulative remission-phase mortality, and adverse event rates. Planned enrollment: 32 participants.

NCT Number	NCT07188740
Lead Sponsor	Institute of Hematology & Blood Diseases Hospital, China
Conditions	DNMT3A Gene Mutation
Enrollment	32 participants
Start Date	2026-08-30
Primary Completion	2027-08-30 (estimated)
Study Completion	2029-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-10