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NCT02259348 · BASELINE

Baseline characteristics

Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation · Source last updated 2017-05-30

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

denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    BG000
    title
    Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.5
          value
          12.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.7
          upper Limit
          19.5
          value
          12.2
      title
      Age, Median
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Not otherwise specified Spanish, Hispanic, Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non Spanish speaking, Non Hispanic
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      AML with 11q23/MLL abnormalities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      AML, multilineage dysplasia with prior MDS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      AML, not otherwise specified
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      AML, without maturation
    description
    AML = acute myeloid leukemia; MLL = myeloid-lymphoid leukemia; MDS = myelodysplastic syndrome
    param Type
    NUMBER
    title
    Primary Diagnosis
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    units
    Participants
groups
  1. description
    Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level. Cyclophosphamide: Given intravenously (IV) Fludarabine: Given IV G-CSF: Given IV or subcutaneously (SQ) Interleukin-2: Given SQ Melphalan: Given IV Thiotepa: Given IV Rituximab: Given IV Natural killer cell therapy: Given IV T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0. CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1.
    id
    BG000
    title
    Participants
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.5
          value
          12.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.7
          upper Limit
          19.5
          value
          12.2
      title
      Age, Median
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Not otherwise specified Spanish, Hispanic, Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non Spanish speaking, Non Hispanic
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      AML with 11q23/MLL abnormalities
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      AML, multilineage dysplasia with prior MDS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      AML, not otherwise specified
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      AML, without maturation
    description
    AML = acute myeloid leukemia; MLL = myeloid-lymphoid leukemia; MDS = myelodysplastic syndrome
    param Type
    NUMBER
    title
    Primary Diagnosis
    unit Of Measure
    participants

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