Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00075478 · BASELINE

Baseline characteristics

Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2017-05-15

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
      41
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      85
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    BG000
    title
    Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
  2. description
    Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    BG001
    title
    Arm II (TBI, Transplant, GVHD Prophylaxis)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          72
          value
          57
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          74
          value
          54.5
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          74
          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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          73
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          58
        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
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Germany
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Italy
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The randomization will be stratified on institution, disease risk (indolent vs. aggressive), and prior conventional HCT and will be balanced (blocked) over time.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      41
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      85
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    BG000
    title
    Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
  2. description
    Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
    id
    BG001
    title
    Arm II (TBI, Transplant, GVHD Prophylaxis)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          72
          value
          57
        2. group Id
          BG001
          lower Limit
          18
          upper Limit
          74
          value
          54.5
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          74
          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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          73
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          58
        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
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Germany
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Italy
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The randomization will be stratified on institution, disease risk (indolent vs. aggressive), and prior conventional HCT and will be balanced (blocked) over time.

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

Preserved source evidence · Not medical advice