Metformin to see if it lowers DNMT3A CH in acute leukemia remission
Official title: Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia: A Single-Arm Clinical Study
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT07188740 · Data updated 2026-11-12
This study tests whether metformin can reduce DNMT3A R882 clonal hematopoiesis in people with acute leukemia who are in remission.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | August 30, 2026 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2029 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07188740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Candidates are 14 years or older with acute leukemia in remission and DNMT3A R882 CH with VAF ≥5%.
✕Probably not a fit
Patients without DNMT3A R882 CH, those who cannot tolerate metformin, or who do not show reduction in VAF may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm Phase 1 trial evaluating the safety and potential efficacy of metformin in patients with acute leukemia who harbor DNMT3A R882 clonal hematopoiesis and are in remission. Participants receive oral metformin, titrated up to 2000 mg per day for 6 months, with monitoring of DNMT3A R882 variant allele frequency (VAF) and clinical outcomes. Primary endpoint is the proportion achieving a meaningful decline in DNMT3A R882 VAF at 6 months; secondary endpoints include earlier VAF changes, relapse-free survival, overall survival, relapse-related outcomes, and adverse events. The study leverages metformin’s proposed effects on mitochondrial metabolism and epigenetic regulation to reduce clonal hematopoiesis-driven risks. Enrollment targets 32 participants at a single center in Tianjin, China.
Why it matters
Potential benefit: If effective, metformin could lower clonal hematopoiesis burden and potentially reduce relapse risk or complication rates for people with DNMT3A R882-driven CH after remission.
How similar studies have gone: Preclinical data and early work in models suggest metformin can impact mutant hematopoietic clones, but this specific approach in humans is investigational with limited prior clinical success data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Patients with diabetes receiving other medications * Known allergy to metformin * Deemed unsuitable by investigator
Where it's running
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Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Hui Wei, MD
- Email: weihui@ihcams.ac.cn
- Phone: 13132507161
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.