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Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies

Study acronym: AB-CliniMACs
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoint(s) modified Show 14 more changesShow less
    • Phase changed: Phase 2 → not applicable
    • Results posted: Oct 6, 2026
    • Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia
    • Trial completed
    • Final enrollment: 98 participants (planned 140)
    • Primary completion date changed from estimate of Oct 2026 to Jul 2025
    • Interventions modified
    • Trial arms changed: 3 → 1
    • Study completion date changed from estimate of Oct 2027 to May 2026
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints shortened, about 9 words
    • Study description expanded, about 299 words
    • Site details revised
    • Publications: 1 to 36
  2. Notable Primary completion date: Oct 2025 to Oct 2026
    • Study completion date: Oct 2026 to Oct 2027
    v17
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  4. Minor Site contact updatedv15
  5. Minor Site contact updatedv14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Enrollment target: 110 to 140
    • Site contact updated
    v13
  2. Notable Primary completion date: Oct 2024 to Oct 2025
    • Enrollment target: 140 to 110
    • Study completion date: Oct 2025 to Oct 2026
    v12
  3. Minor Enrollment target: 120 to 140v11
  4. Minor Enrollment target: 150 to 120
    • Site contact updated
    v10
  5. Minor Enrollment target: 110 to 150
    • Study completion date: Jun 2025 to Oct 2025
    v9
  6. Notable Primary completion date: Oct 2019 to Oct 2024
    • Enrollment target: 100 to 110
    • Study completion date: Jun 2020 to Jun 2025
    v8
  7. Notable Enrollment target: 60 to 100
    • Eligibility criteria expanded, about 4 words
    v7
  8. Minor 4 versions Re-verified since Oct 19, 2015, no change to tracked fieldsv3-v6
  9. Minor Eligibility criteria expanded, about 45 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T cells and CD19+ B cells using the CliniMACS device. The study assesses engraftment, graft-versus-host disease (GVHD), treatment-related mortality, immune reconstitution, and one-year leukemia-free survival in patients with hematologic malignancies.
Trial Details
NCT Number NCT02323867
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)
Leukemia, Lymphoma, Myelodysplasia
Related terms Anemia, Refractory, with Excess of Blasts, Leukemia, Lymphoma
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov