Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01158118 · BASELINE

Baseline characteristics

Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors · Source last updated 2017-06-05

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
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      48
    units
    Participants
groups
  1. description
    Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors) Day 5: Mobilization with 320 mcg/kg plerixafor IV Day 5: Leukopheresis If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.
    id
    BG000
    title
    Arm 1 - Donor
  2. description
    Conditioning Regimens * fludarabine and busulfan +/- thymoglobulin * fractionated total body irradiation and cyclophosphamide * busulfan and cyclophosphamide * single dose total body irradiation and cyclophosphamide Day -2 = GvHD prophylaxis Day 0 or +1 = PBSC transplant Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day
    id
    BG001
    title
    Arm 2 - Recipient
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          65
          value
          53
        2. group Id
          BG001
          lower Limit
          32
          upper Limit
          64
          value
          57
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          65
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          27
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      48
    units
    Participants
groups
  1. description
    Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors) Day 5: Mobilization with 320 mcg/kg plerixafor IV Day 5: Leukopheresis If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6.
    id
    BG000
    title
    Arm 1 - Donor
  2. description
    Conditioning Regimens * fludarabine and busulfan +/- thymoglobulin * fractionated total body irradiation and cyclophosphamide * busulfan and cyclophosphamide * single dose total body irradiation and cyclophosphamide Day -2 = GvHD prophylaxis Day 0 or +1 = PBSC transplant Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day
    id
    BG001
    title
    Arm 2 - Recipient
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          65
          value
          53
        2. group Id
          BG001
          lower Limit
          32
          upper Limit
          64
          value
          57
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          65
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          27
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          48
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice