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

NCT04741945 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-22

No results posted yet for this study

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).

Conditions

  • Preleukemia
  • Myelodysplastic Neoplasm
  • Cytopenia
  • Preleukemic Anemia

Interventions

DRUG

Metformin

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

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Van Andel Research Institute

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Technical University of Denmark

    collaborator OTHER

  • Region Hovedstadens Apotek

    collaborator OTHER_GOV

  • University of Copenhagen

    collaborator OTHER

  • Kirsten Grønbæk

    lead OTHER

Principal Investigators

  • Kirsten Grønbæk, Professor, MD · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741945 on ClinicalTrials.gov