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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 22, 2024 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jul 2025 to Feb 2026
    • Study completion date: Jun 2026 to Feb 2026
    • Site contact updated
    v5
  2. Enrollment target: 24 to 40v4 Show 6 more changesShow less
    • Primary endpoints: 1 to 5
    • Eligibility criteria expanded, about 183 words
    • Secondary endpoints: 15 to 25
    • Study description expanded, about 151 words
    • Site contact updated
    • Collaborators: 8 to 7
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary completion date: Nov 2024 to Jul 2025
    • Start date changed from estimate of Aug 2021 to Dec 13, 2021
    • Study completion date: Nov 2025 to Jun 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 13 to 15
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04741945
Lead Sponsor Kirsten Grønbæk
Collaborators: Steno Diabetes Center Copenhagen, Zealand University Hospital, Van Andel Research Institute, Herlev Hospital, Technical University of Denmark, Region Hovedstadens Apotek, University of Copenhagen
Conditions
(from sponsor)		 Preleukemia, Myelodysplastic Neoplasm, Cytopenia, Preleukemic Anemia
Related terms Anemia, Refractory, with Excess of Blasts, Cytopenia, Preleukemia
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov