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Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Feb 2025 to Dec 2028v5 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 154 to 204
    • Study completion date: Feb 2025 to Dec 2030
    • Eligibility criteria expanded, about 278 words
    • Secondary endpoints: 7 to 5
    • Site contact updated
    • Study arms: 2 to 3
  2. Enrollment target: 50 to 154
    • Primary endpoints: 3 to 1
    • Secondary endpoints: 5 to 7
    • Study arms: 1 to 2
    v4
  3. Site contact updatedv3
  4. Start date changed from estimate of Feb 2020 to Feb 1, 2020v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.
Trial Details
NCT Number NCT04249830
Lead Sponsor Alice Bertaina
Conditions
(from sponsor)		 Hematologic Diseases
Related terms Hematologic Diseases
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov