Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia

Recruiting now · Phase 1

Conditions studied: DNMT3A Gene Mutation

In brief

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.

Key facts

Study ID: NCT07188740
Run by: Institute of Hematology & Blood Diseases Hospital, China
People needed: 32
Starts: 2026-08-30
Expected to finish: 2029-08-30
Last updated by the study team: 2026-08-10

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients diagnosed with acute leukemia based on bone marrow morphology, immunology, and genetics, per WHO 2022 or ICC criteria.
Patients in complete remission follow-up phase with DNMT3A R882 mutation clonal hematopoiesis, VAF ≥5%.
Age ≥14 years, any gender
Laboratory requirements (within 7 days before treatment):
Total bilirubin ≤1.5 × upper limit of normal (ULN) for age.
AST and ALT ≤2.5 × ULN for age.
Serum creatinine <2 × ULN for age.
Cardiac enzymes <2 × ULN for age.
Ejection fraction within normal range by echocardiogram (ECHO).
Signed informed consent: By patient (≥18 years) or legal guardian/relative (<18 years or if beneficial for condition).

You may not qualify if…

Patients with diabetes receiving other medications
Known allergy to metformin
Deemed unsuitable by investigator

Where it is running

Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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