RecruitingPhase 2NCT04741945

Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS

STOP-LEUKEMIA: Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS


Sponsor

Kirsten Grønbæk

Enrollment

40 participants

Start Date

Dec 13, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether metformin — a common diabetes drug — can prevent low-risk bone marrow conditions (called CCUS and low-risk MDS) from progressing into more serious blood cancers like leukemia. **You may be eligible if...** - You have been diagnosed with low-risk MDS (very low or low risk by the IPSS-R scoring system) OR a condition called CCUS (persistent low blood counts with genetic changes, but not yet diagnosed as MDS or leukemia) - Your bone marrow blast percentage is under 5% - You have had persistent low blood counts for at least 6 months - You are in generally adequate health **You may NOT be eligible if...** - Your MDS is classified as intermediate, high, or very high risk - You are already taking metformin for diabetes or another reason - You have significant kidney problems (metformin is not safe with poor kidney function) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

2000 mg/day metformin for 12 months (1000 mg b.i.d.) with a slow up-titration six weeks prior to full dose treatment.


Locations(1)

Rigshospitalet

Copenhagen, Copenhagen N, Denmark

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NCT04741945


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