CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

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  1. Trial status changed: Suspended → Not Yet Recruiting Show 9 more changesShow less
    • Phase: Phase 2 to Not applicable
    • Primary and study completion dates: Jun 2033 to Jan 2034
    • Start date: Jun 2026 to Jan 2027
    • Primary endpoints: 6 to 1
    • Enrollment target: 50 to 62
    • Eligibility criteria expanded, about 315 words
    • Secondary endpoints: 1 to 5
    • Study site revised
    • Publications: details revised at 7 of 8 entries
  2. Primary and study completion dates: Sep 2032 to Jun 2033
    • Start date: Jan 2026 to Jun 2026
    v15
  3. Start date: Sep 2025 to Jan 2026v14
  4. Start date: Mar 2025 to Sep 2025
    • Primary and study completion dates: Mar 2032 to Sep 2032
    v13
  5. Start date: Oct 2024 to Mar 2025
    • Primary and study completion dates: Oct 2031 to Mar 2032
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Jun 2024 to Oct 2024
    • Primary and study completion dates: Jun 2031 to Oct 2031
    v11
  2. Lead sponsor: Baptist Health South Florida to Guenther Koehne
    • Start date: Mar 2024 to Jun 2024
    • Primary and study completion dates: Mar 2031 to Jun 2031
    v10
  3. Start date: Sep 2023 to Mar 2024
    • Primary and study completion dates: Sep 2030 to Mar 2031
    v9
  4. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: The study has been put on hold while pending CMS approval
    • Site contact updated
    v8
  5. Start date: Jul 2023 to Sep 2023
    • Primary and study completion dates: Jul 2030 to Sep 2030
    v7
  6. Start date: May 2023 to Jul 2023
    • Primary and study completion dates: May 2030 to Jul 2030
    v6
  7. Start date: Mar 2023 to May 2023
    • Primary and study completion dates: Mar 2030 to May 2030
    v5
  8. Primary and study completion dates: Jan 2030 to Mar 2030
    • Start date: Feb 2023 to Mar 2023
    v4
  9. Start date: Dec 2022 to Feb 2023v3
  10. Eligibility criteria expanded, about 48 words
    • Study title shortened, about 4 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in fewer complications for patients who undergo transplant to treat myelodysplastic syndrome (MDS). The CliniMACS system will be used to remove immune T-cells from the transplant donor's blood. Immune T-cells contribute to graft versus host disease (GVHD) - a serious complication that can happen after transplant. GVHD occurs when a patient's immune system attacks the donor's cells. The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD.
Trial Details
NCT Number NCT05617625
Lead Sponsor Guenther Koehne
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Graft Vs Host Disease, Graft-versus-host-disease
Related terms Graft vs Host Disease, Myelodysplastic Syndromes
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov