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STOP-LEUKEMIA: Repurposing metformin as a leukemia-preventive drug in CCUS and LR-MDS
EU CTIS ID: 2024-518436-37-01
What this study is testing
The purpose of this pilot study is to investigate safety of metformin and feasibility of the study protocol in patients with clonal cytopenia of undetermined significance (CCUS) and lower-risk myelodysplastic syndromes (LR-MDS) and examine potential mechanisms of action of metformin in controlling disease progression in order to inform the design of a future phase 3 randomized controlled trial (RCT) of the efficacy of metformin in CCUS and LR-MDS patients.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Work Package (WP) 0: • Healthy individuals matched on age, sex, and BMI, if possible, to individual patient participants in WP1. • Written informed consent prior to study procedures. • Willingness to comply with mandatory aspects of the protocol.
- WP1: • A diagnosis of: o MDS of very low- or low-risk according to the revised international prognostic scoring system (IPSS-R; IPSS-R score ≤3) in addition to a bone marrow blast percentage of <5% OR o 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 hemolytic conditions have been ruled out. Peripheral blood (PB) 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, thrombocytes <150 x 109/L, or neutrophilocytes <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. • Written informed consent prior to study procedures. • Willingness to comply with mandatory aspects of the protocol. • Ability to swallow pills.
You likely can't join if
- WP0: • 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 magnetic resonance scanning (MRS).
- WP1: • 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 G-CSF 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, disabling psychiatric disease, severe neurologic disease, uncontrolled metabolic disease, or severe cardiac disease (NYHA class 3‐4).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.