Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
Status:
NOT_YET_RECRUITING
Trial end date:
2029-08-30
Target enrollment:
Participant gender:
Summary
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: 30 participants.
Phase:
PHASE1
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China