About this trial
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
Qualifiers
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 months, without any other obvious pathological or physiological cause
≥18 years of age
Disqualifiers
Any prior treatment with metformin
A diagnosis of diabetes mellitus
Therapeutic radiation, immunosuppressive therapy (with the exception of corticosteroids), or chemotherapy within the past year
Treatment with granulocyte colony-stimulating factor within the past 30 days
Trial design
Treatments tested in this trial
- Metformin
Treatment groups
Sponsors and collaborators
Kirsten Grønbæk
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Steno Diabetes Center Copenhagen
Collaborator
Zealand University Hospital
Collaborator
Van Andel Research Institute
Collaborator
Herlev Hospital
Collaborator
Technical University of Denmark
Collaborator
Region Hovedstadens Apotek
Collaborator
University of Copenhagen
Collaborator