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Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia

RecruitingPhase 1Ages 14 Years - anyAllInstitute of Hematology & Blood Diseases Hospital…
NCT07188740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Metformin
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Where

1 site
Blood Diseases Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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