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Alpha/Beta T-cell Depleted Blood-forming Stem Cell Transplant From Related or Unrelated Donors for Blood Diseases in Children and Young Adults

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened
    • Start date pushed from Sep 2026 to Oct 2026
    • Study sites: 0 to 1
  2. Minor Start date: Sep 2026 to Oct 2026
    • Interventions: CliniMACS® System (Device), TCRαβ+/CD19+ depleted Hematopoietic stem cell (HSC) graft (Biological) to CliniMACS® System (Device), TCRαβ+/CD19+ depleted Hematopoietic stem cell (HSC) graft (Biological)
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 5 of 15 entries
  3. Minor Start date: Aug 2026 to Sep 2026v40
  4. Minor Primary completion pushed from May 2029 to Jun 2029
    • Study completion pushed from May 2030 to Jun 2030
    • Start date: Jul 2026 to Aug 2026
    v39
  5. Minor Start date: Jun 2026 to Jul 2026v38
Show 36 earlier versionsHide 36 earlier versions
  1. Notable Start date: Apr 2026 to Jun 2026v37 Show 4 more changesShow less
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints revised (15)
    • Primary endpoints revised (4)
    • Study description expanded, about 308 words
  2. Minor Re-verified, no change to tracked fieldsv36
  3. Notable Start date: Jan 2026 to Apr 2026
    • Primary completion date: Feb 2029 to May 2029
    • Study completion date: Feb 2030 to May 2030
    v35
  4. Notable Start date: Nov 2025 to Jan 2026
    • Primary completion date: Dec 2028 to Feb 2029
    • Study completion date: Dec 2029 to Feb 2030
    v34
  5. Notable Start date: Sep 2025 to Nov 2025v33
  6. Notable Start date: Jul 2025 to Sep 2025
    • Primary completion date: Oct 2028 to Dec 2028
    • Study completion date: Oct 2029 to Dec 2029
    v32
  7. Notable Start date: Apr 2025 to Jul 2025
    • Primary completion date: Jul 2028 to Oct 2028
    • Study completion date: Jul 2029 to Oct 2029
    v31
  8. Notable Start date: Jan 2025 to Apr 2025v30
  9. Notable Start date: Nov 2024 to Jan 2025
    • Primary completion date: May 2028 to Jul 2028
    • Study completion date: May 2029 to Jul 2029
    v29
  10. Notable Start date: Aug 2024 to Nov 2024v28
  11. Notable Start date: Jun 2024 to Aug 2024
    • Primary completion date: Mar 2028 to May 2028
    • Study completion date: Mar 2029 to May 2029
    v27
  12. Notable Start date: Mar 2024 to Jun 2024v26
  13. Notable Start date: Dec 2023 to Mar 2024v25
  14. Notable Start date: Oct 2023 to Dec 2023v24
  15. Minor Start date: Sep 2023 to Oct 2023v23
  16. Minor Start date: Aug 2023 to Sep 2023v22
  17. Minor Start date: Jul 2023 to Aug 2023v21
  18. Minor Start date: Jun 2023 to Jul 2023v20
  19. Minor Start date: May 2023 to Jun 2023v19
  20. Minor Start date: Apr 2023 to May 2023v18
  21. Notable Primary completion date: May 2026 to Mar 2028
    • Study completion date: May 2027 to Mar 2029
    • Start date: Mar 2023 to Apr 2023
    v17
  22. Minor Re-verified, no change to tracked fieldsv16
  23. Notable Start date: Dec 2022 to Mar 2023
    • Primary completion date: Feb 2026 to May 2026
    • Study completion date: Feb 2027 to May 2027
    v15
  24. Notable Start date: Oct 2022 to Dec 2022v14
  25. Notable Start date: Aug 2022 to Oct 2022v13
  26. Minor Start date: Jul 2022 to Aug 2022v12
  27. Minor Start date: Jun 2022 to Jul 2022v11
  28. Notable Start date: Apr 2022 to Jun 2022v10
  29. Minor Start date: Mar 2022 to Apr 2022v9
  30. Notable Start date: Dec 2021 to Mar 2022v8
  31. Notable Start date: Oct 2021 to Dec 2021v7
  32. Notable Start date: Aug 2021 to Oct 2021v6
  33. Minor Start date: Jul 2021 to Aug 2021v5
  34. Minor Start date: Jun 2021 to Jul 2021v4
  35. Minor Start date: May 2021 to Jun 2021v3
  36. Minor Start date: Apr 2021 to May 2021v2
  1. 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.
This study is being done to see if the investigators can take peripheral blood stem cells from either an adult family member or a closely matched unrelated donor, and run them through a special lab instrument to remove alpha/beta T cells and B cells and then give them to the patient to treat disease. This is an experimental way of doing a hematopoietic stem cell transplant (HSCT). The investigators want to see if the new stem cells will grow without bad graft vs. host disease (GVHD). This treatment approach is experimental in the United States.
Trial Details
NCT Number NCT04806347
Lead Sponsor University of Wisconsin, Madison
Conditions
(from sponsor)
Blood Disease
Related terms Hematologic Diseases
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov