NCT04741945 Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS
| NCT ID | NCT04741945 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Kirsten Grønbæk |
| Condition | Preleukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2026-02 |
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Patients are eligible to be included in WP1 if they meet all of the following criteria: Inclusion criteria: * A diagnosis of: * LR-MDS according to the revised international prognostic scoring system (IPSS-R), i.e., very low- or low-risk disease (IPSS-R score ≤3) in addition to a bone marrow blast percentage \<5 OR * CCUS defined as the presence of somatic mutation(s) or cytogenetic abnormality not diagnostic of MDS or any other malignancy in the context of persistent cytopenia (\>6 months) with other common causes of cytopenia ruled out in the setting of bone marrow morphology that is not diagnostic of MDS or any other malignancy, and hematolytic conditions have been ruled out. 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 109/L, or neutrophil count \<1.8 x 109/L * Menopause, if being a female, defined as females \>45 years of age who have experienced amenorrhea for minimum 12 mon
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