Actively Recruiting
Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS
Led by Kirsten Grønbæk · Updated on 2024-11-22
40
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
K
Kirsten Grønbæk
Lead Sponsor
S
Steno Diabetes Center Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lower-risk myelodysplastic neoplasms (LR-MDS) with IPSS-R score or bone marrow blasts <5%, OR diagnosis of clonal cytopenia of undetermined significance (CCUS) with persistent cytopenia >6 months and other causes ruled out
- Women must be menopausal (over 45 years old with at least 12 months of amenorrhea) if female
- Age 18 years or older
- Written informed consent provided
- Willingness to follow mandatory study procedures
- Ability to swallow pills
You will not qualify if you...
- Prior treatment with metformin
- Diagnosis of diabetes mellitus
- Radiation therapy, immunosuppressive therapy (except corticosteroids), or chemotherapy within the past year
- Treatment with granulocyte colony-stimulating factor within the past 30 days
- Prior therapy with hypomethylating agents (azacitidine, decitabine)
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min
- Eastern Cooperative Oncology Group performance status greater than 2
- Other active malignancy within the past five years
- Uncontrolled comorbidities including impaired liver function, chronic hepatitis with decompensated cirrhosis, severe psychiatric or neurological diseases, uncontrolled metabolic disease, or severe heart disease (NYHA class 3-4)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, Copenhagen N, Denmark, 2200
Actively Recruiting
Research Team
K
Kirsten Grønbæk, Professor, MD
CONTACT
S
Stine Ulrik Mikkelsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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