Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00089011 · BASELINE

Baseline characteristics

Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for Hematologic Cancer · Source last updated 2020-01-29

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
      100
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      150
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
  2. description
    Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
    id
    BG001
    title
    Arm II (Nonmyeloablative Conditioning With TBI)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          123
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          27
        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
          value
          46
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          87
        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
          98
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          144
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      Italy
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      100
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      150
    units
    Participants
groups
  1. description
    Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. fludarabine phosphate: Given IV total-body irradiation: Undergo radiotherapy laboratory biomarker analysis: Correlative studies
    id
    BG000
    title
    Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)
  2. description
    Patients undergo TBI on day 0. All patients then undergo allogeneic peripheral blood stem cell transplantation on day 0 and receive tacrolimus PO every 12 hours on days -3 to 180, with taper on day 56, or tacrolimus IV if unable to tolerate PO; and mycophenolate mofetil PO every 12 hours on days 0-27 or mycophenolate mofetil IV if unable to tolerate PO. total-body irradiation: Undergo radiotherapy mycophenolate mofetil: Given IV or PO tacrolimus: Given IV or PO peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplant laboratory biomarker analysis: Correlative studies
    id
    BG001
    title
    Arm II (Nonmyeloablative Conditioning With TBI)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          123
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          27
        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
          value
          46
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          87
        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
          98
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          144
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      Italy
    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