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Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
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.
Official title: Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia: A Single-Arm Clinical Study
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-30
Completion Date
2029-08-30
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
Metformin
Start at 500 mg twice daily, titrate to 2000 mg/day for 6 months