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A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

Study acronym: EPO-PRETAR
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date changed from estimate of May 16, 2022 to Sep 21, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: May 16, 2024 to Oct 1, 2028
    • Site details revised at 39 of 39 sites
    v7
  3. Study sites: 29 to 39v6
  4. Primary completion date: Oct 1, 2019 to May 16, 2022
    • Start date: Jan 1, 2018 to Mar 26, 2018
    • Study sites: 28 to 29
    • Study completion date: Oct 1, 2021 to May 16, 2024
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 28 of 28 sites
    v4
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  1. Start date: Dec 1, 2017 to Jan 1, 2018v3
  2. Start date: Oct 1, 2017 to Dec 1, 2017v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 an open-label, randomized, multicenter, phase III study Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks: * Either at diagnosis Or * at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)
Trial Details
NCT Number NCT03223961
Lead Sponsor Groupe Francophone des Myelodysplasies
Conditions
(from sponsor)		 Myelodysplastic Syndromes
Related terms Myelodysplastic Syndromes
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov