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New treatment option for Preleukemia
Official title Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS
ClinicalTrials.gov ID: NCT04741945
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preleukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients are eligible to be included in WP1 if they meet all of the following 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...
- CCUS defined as the presence of somatic mutation(s) or cytogenetic abnormality not diagnostic of MDS or any other malignancy in the context of...
- Menopause, if being a female, defined as females \>45 years of age who have experienced amenorrhea for minimum 12 months, without any other obvious...
You likely can't join if
- 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
- Prior therapy with hypomethylating agents (i.e., azacitidine, decitabine)
- eGFR \<45 mL/min
See the full eligibility criteria
- Patients are eligible to be included in WP1 if they meet all of the following 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...
- 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
- Written informed consent
- Willingness to comply with mandatory aspects of the protocol
- Ability to swallow pills
- 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
- Prior therapy with hypomethylating agents (i.e., azacitidine, decitabine)
- eGFR \<45 mL/min
- Performance status according to the Eastern Cooperative Oncology Group \>2
- Other active malignancy within the past five years
- Uncontrolled comorbidity including impaired hepatic function (total serum bilirubin \>1.5 × upper limit of the normal range (ULN), serum alanine transaminase \>3 × ULN), chronic hepatitis with decompensated cirrhosis...
- Healthy individuals matched on age, sex, and BMI, if possible, to individual patient participants in WP1
- Written informed consent
- Willingness to comply with mandatory aspects of the protocol Exclusion criteria:
- Use of metformin within the past 3 years
- A diagnosis of diabetes mellitus, rheumatological disorders, autoimmune diseases or other inflammatory disorders, celiac disease, inflammatory bowel disease, or other gastrointestinal disorders or symptoms
- Treatment with immunosuppressive drugs (with the exception of corticosteroids) or chemotherapy within the past year or antibiotics within the past 6 months
- Any contraindications to MRS
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Copenhagen N, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Copenhagen N, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.