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NCT00241358 · BASELINE

Baseline characteristics

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies · Source last updated 2017-06-06

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
      25
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      92
    units
    Participants
groups
  1. description
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    id
    BG000
    title
    Subcutaneous (SC) Treatment Plan - Donor
  2. description
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    id
    BG001
    title
    Recipients
  3. description
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    id
    BG002
    title
    Intravenous (IV) Treatment Plan - Donor
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          66
          value
          54
        2. group Id
          BG001
          lower Limit
          23
          upper Limit
          66
          value
          53
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          67
          value
          51
        4. group Id
          BG003
          lower Limit
          21
          upper Limit
          67
          value
          52
    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
          5
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          53
        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
          25
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          92
      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
      25
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      92
    units
    Participants
groups
  1. description
    * Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    id
    BG000
    title
    Subcutaneous (SC) Treatment Plan - Donor
  2. description
    * Conditioning Regimen * Cyclophosphamide 60mg/kg/day on Days -3 and -2 * TBI 550cGy on Day -1 * GVHD prophylaxis \*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100 * PBSC transplant on Day 0
    id
    BG001
    title
    Recipients
  3. description
    * Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis * Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis * If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
    id
    BG002
    title
    Intravenous (IV) Treatment Plan - Donor
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          66
          value
          54
        2. group Id
          BG001
          lower Limit
          23
          upper Limit
          66
          value
          53
        3. group Id
          BG002
          lower Limit
          21
          upper Limit
          67
          value
          51
        4. group Id
          BG003
          lower Limit
          21
          upper Limit
          67
          value
          52
    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
          5
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          53
        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
          25
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          92
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice