OncoMatch/Clinical Trials/NCT04741945
Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS
Is NCT04741945 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Metformin for preleukemia.
Treatment: Metformin — This is a single-arm pilot study of the feasibility and safety of metformin in patients with clonal cytopenia of undetermined significance (CCUS) or lower-risk myelodysplastic neoplasms (LR-MDS).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Disease stage
Required: Stage VERY LOW-RISK, LOW-RISK (IPSS-R)
very low- or low-risk disease (IPSS-R score ≤3) in addition to a bone marrow blast percentage <5
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: metformin
Any prior treatment with metformin
Cannot have received: immunosuppressive therapy
Exception: corticosteroids
immunosuppressive therapy (with the exception of corticosteroids) within the past year
Cannot have received: chemotherapy
chemotherapy within the past year
Cannot have received: granulocyte colony-stimulating factor
Treatment with granulocyte colony-stimulating factor within the past 30 days
Cannot have received: hypomethylating agents (azacitidine, decitabine)
Prior therapy with hypomethylating agents (i.e., azacitidine, decitabine)
Lab requirements
Blood counts
Peripheral blood cytopenia is defined as hemoglobin (hgb) <11.3 g/dL (7 mmol/L) in women and hgb <12.9 g/dL (8 mmol/L) in men, platelet count <150 x 10^9/L, or neutrophil count <1.8 x 10^9/L
Kidney function
eGFR <45 mL/min
Liver function
total serum bilirubin >1.5 × upper limit of the normal range (ULN), serum alanine transaminase >3 × ULN
Cardiac function
severe cardiac disease (NYHA class 3-4)
eGFR <45 mL/min; total serum bilirubin >1.5 × ULN, serum alanine transaminase >3 × ULN; severe cardiac disease (NYHA class 3-4); Peripheral blood cytopenia is defined as hemoglobin (hgb) <11.3 g/dL (7 mmol/L) in women and hgb <12.9 g/dL (8 mmol/L) in men, platelet count <150 x 10^9/L, or neutrophil count <1.8 x 10^9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04741945 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior metformin, immunosuppressive therapy, chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage VERY LOW-RISK or LOW-RISK is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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