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Second STOP After Pioglitazone Priming in CML Patients

Study acronym: PIO2STOP
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Primary completion date: Dec 2021 to Dec 2027
    • Study sites: 4 to 6
    • Study completion date: Dec 2021 to Dec 2028
    • Collaborators shortened, about 3 words
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary and study completion dates: Oct 2018 to Dec 2021
    • Start date: Oct 2016 to Dec 2016
    • Study sites: 1 to 4
    • Eligibility criteria expanded, about 12 words
    • Collaborators expanded, about 3 words
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Single-center study, prospective, phase II trial. The study objectives are : * To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation. * To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.
Trial Details
NCT Number NCT02889003
Lead Sponsor Versailles Hospital
Conditions
(from sponsor)
Chronic Myeloid Leukemia (CML)
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov