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T-Cell Depleted Alternative Donor Bone Marrow Transplant for Sickle Cell Disease (SCD) and Other Anemias

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 1, 2026 → Aug 1, 2028
See other at-risk trials from Paul Szabolcs

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 1, 2026 to Aug 1, 2028
    • Study completion pushed from Aug 1, 2027 to Aug 1, 2028
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Primary completion date: Aug 1, 2025 to Aug 1, 2026
    • Study completion date: Aug 1, 2026 to Aug 1, 2027
    v14
  4. Primary completion date: Aug 1, 2024 to Aug 1, 2025v13
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Aug 1, 2023 to Aug 1, 2024
    • Study completion date: Aug 1, 2025 to Aug 1, 2026
    v11
  2. 2 versions Re-verified since May 3, 2021, no change to tracked fieldsv9-v10
  3. Lead sponsor: University of Pittsburgh to Paul Szabolcsv8
  4. Lead sponsor: Beth Carella, DO to University of Pittsburgh
    • Site contact updated
    v7
  5. Study site revisedv6
  6. Re-verified, no change to tracked fieldsv5
  7. Study title expanded, about 2 wordsv4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2018 to Aug 2, 2018
    • Site details revised
    v3
  9. Start date: Aug 2018 to Sep 2018
    • Interventions: Alemtuzumab (Drug), CD3/CD19 Hematopoietic Stem Cells (Biological), CD45RA Hematopoietic Stem Cells (Biological), Fludarabine (Drug)… to Alemtuzumab (Drug), CD3/CD19 depleted leukocytes (Biological), CD45RA depleted leukocytes (Biological), Fludarabine (Drug), Hydroxyurea…
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate what effect, if any, mismatched unrelated volunteer donor and/or haploidentical related donor stem cell transplant may have on severe sickle cell disease and other transfusion dependent anemias. By using mismatched unrelated volunteer donor and/or haploidentical related donor stem cells, this study will increase the number of patients who can undergo a stem cell transplant for their specified disease. Additionally, using a T-cell depleted approach should reduce the incidence of graft-versus-host disease which would otherwise be increased in a mismatched transplant setting.
Trial Details
NCT Number NCT03653338
Lead Sponsor Paul Szabolcs
Conditions
(from sponsor)		 Sickle Cell Anemia, Beta-thalassemia Major, Diamond-blackfan Anemia
Related terms Anemia, Anemia, Diamond-Blackfan, Anemia, Sickle Cell, beta-Thalassemia
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov