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Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from May 2026 to May 2029v12
  2. Primary and study completion dates: Nov 2025 to May 2026v11
  3. Re-verified, no change to tracked fieldsv10
  4. Primary completion date: Sep 12, 2023 to Nov 2025 Completion date: Sep 12, 2024 to Nov 2025v9 Show 1 more changeShow less
    • Completion date: Sep 12, 2024 to Nov 2025
  5. 3 versions Re-verified since Oct 5, 2020, no change to tracked fieldsv6-v8
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Terminated to Recruiting Enrollment target: 2 to 50 · Primary completion date: Sep 12, 2018 to Sep 12, 2023 · Completion date: Sep 12, 2018 to Sep 12, 2024 · 2 morev5 Show 5 more changesShow less
    • Enrollment target: 2 to 50
    • Primary completion date: Sep 12, 2018 to Sep 12, 2023
    • Completion date: Sep 12, 2018 to Sep 12, 2024
    • Start date: Apr 28, 2017 to Mar 20, 2017
    • Site details revised
  2. Trial status: Recruiting to Terminated Sponsor's reason: Only 2 subjects were enrolled Enrollment target: estimated 50 to confirmed 2 · Primary and study completion dates changed from estimate of Oct 28, 2026 to Sep 12, 2018 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 50 to confirmed 2
    • Primary and study completion dates changed from estimate of Oct 28, 2026 to Sep 12, 2018
    • Site details revised
  3. 2 versions Re-verified since May 17, 2017, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study is a Phase II clinical trial. Patients will receive intensity modulated total body irradiation (TBI) at a dose of 3 Gy with standard fludarabine/ i.v. cyclophosphamide conditioning prior to human leukocyte antigen (HLA)-haploidentical hematopoietic stem cell transplant (HSCT). The primary objective of the study is to determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease.
Trial Details
NCT Number NCT03121001
Lead Sponsor University of Illinois at Chicago
Conditions Sickle Cell Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov