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NCT01231412 · BASELINE

Baseline characteristics

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant · Source last updated 2026-04-30

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
      77
    2. group Id
      BG001
      value
      91
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      174
    units
    Participants
groups
  1. description
    Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
    id
    BG000
    title
    Arm I (MMF and CSP)
  2. description
    Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
    id
    BG001
    title
    Arm II (MMF, CSP, and Sirolimus)
  3. description
    Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
    id
    BG002
    title
    Arm 0 (CSP and Sirolimus)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          106
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          68
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.2
          upper Limit
          77.09
          value
          61.94
        2. group Id
          BG001
          lower Limit
          41.02
          upper Limit
          79
          value
          63.75
        3. group Id
          BG002
          lower Limit
          36.47
          upper Limit
          67.83
          value
          59.515
        4. group Id
          BG003
          lower Limit
          18.2
          upper Limit
          79
          value
          62.655
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          117
        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
          65
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          149
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      77
    2. group Id
      BG001
      value
      91
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      174
    units
    Participants
groups
  1. description
    Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
    id
    BG000
    title
    Arm I (MMF and CSP)
  2. description
    Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
    id
    BG001
    title
    Arm II (MMF, CSP, and Sirolimus)
  3. description
    Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
    id
    BG002
    title
    Arm 0 (CSP and Sirolimus)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          106
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          68
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18.2
          upper Limit
          77.09
          value
          61.94
        2. group Id
          BG001
          lower Limit
          41.02
          upper Limit
          79
          value
          63.75
        3. group Id
          BG002
          lower Limit
          36.47
          upper Limit
          67.83
          value
          59.515
        4. group Id
          BG003
          lower Limit
          18.2
          upper Limit
          79
          value
          62.655
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          57
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          117
        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
          65
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          149
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          22
      title
      Denmark
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Germany
    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