NCT07188740RecruitingPhase 1
Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia: A Single-Arm Clinical Study
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 16 Sept 2025
- Start date
- Aug 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Childhood cancers
- NCT number
- NCT07188740
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From Aug 2026 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with diabetes receiving other medications
Other illness
- Known allergy to metformin
Other
- Deemed unsuitable by investigator
Who the study is looking for
- 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).
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.