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RECRUITING
NCT07188740
PHASE1

Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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: 32 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

32

Start Date

2026-08-30

Completion Date

2029-08-30

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

DRUG

Metformin

Start at 500 mg twice daily, titrate to 2000 mg/day for 6 months

Locations (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China