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Recruiting
NCT07188740
Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
Conditions: DNMT3A Gene Mutation
Sex: All
Ages: 14 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 32
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Location: Blood Diseases Hospital Tianjin Tianjin Municipality
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.
Eligibility 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 \
Source: ClinicalTrials.gov (NCT07188740). StuddyBuddy aggregates publicly available trial information.