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NCT01858740 · FLOW

Participant flow

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children · Source last updated 2024-03-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -7, receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant Tacrolimus: Given IV or PO Thiotepa: Given IV Total-Body Irradiation: Undergo TBI
    id
    FG000
    title
    Treatment (CD45RA+ T Cell Depleted PBSCT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      Day 28 Post Transplant
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      Day 100 Post Transplant
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      1 Year Post Transplant
    5. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 20 patients enrolled, all 20 met inclusion criteria and went forward to be treated on the study.
recruitment Details
Participants were recruited based on referral for Hematopoietic Cell transplant at Fred Hutchinson Cancer Center between March 2014 and January 2017. The first participant was enrolled on April 10, 2014 and the last participant was enrolled on January 27, 2017.
Complete source fields
groups
  1. description
    CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -7, receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Methotrexate: Given IV Peripheral Blood Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant Tacrolimus: Given IV or PO Thiotepa: Given IV Total-Body Irradiation: Undergo TBI
    id
    FG000
    title
    Treatment (CD45RA+ T Cell Depleted PBSCT)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      Day 28 Post Transplant
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      Day 100 Post Transplant
    4. achievements
      1. group Id
        FG000
        num Subjects
        18
      type
      1 Year Post Transplant
    5. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 20 patients enrolled, all 20 met inclusion criteria and went forward to be treated on the study.
recruitment Details
Participants were recruited based on referral for Hematopoietic Cell transplant at Fred Hutchinson Cancer Center between March 2014 and January 2017. The first participant was enrolled on April 10, 2014 and the last participant was enrolled on January 27, 2017.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice