Status:
NOT_YET_RECRUITING
Metformin Inhibits DNMT3A Clonal Hematopoiesis in Acute Leukemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
DNMT3A Gene Mutation
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief 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...
Detailed Description
Clonal hematopoiesis (CHIP) involves hematopoietic stem cells (HSCs) acquiring mutations like DNMT3A R882, conferring a proliferative advantage and increasing risks of hematologic malignancies and inf...
Eligibility Criteria
Inclusion
- 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
- Patients with diabetes receiving other medications
- Known allergy to metformin
- Deemed unsuitable by investigator
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07188740
Start Date
October 30 2025
End Date
August 30 2029
Last Update
September 23 2025
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