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NCT00397813 · BASELINE

Baseline characteristics

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders · Source last updated 2020-01-31

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
      36
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      12
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      77
    units
    Participants
groups
  1. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG000
    title
    Arm A - Dose Level 1
  2. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG001
    title
    Arm A - Dose Level 2
  3. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG002
    title
    Arm A - Dose Level 3
  4. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG003
    title
    Arm B - Dose Level 1
  5. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG004
    title
    Arm B - Dose Level 2
  6. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG005
    title
    Arm B - Dose Level 3
  7. description
    Total of all reporting groups
    id
    BG006
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          47
        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
          37
          upper Limit
          72
          value
          64.5
        2. group Id
          BG003
          lower Limit
          58
          upper Limit
          72
          value
          66.5
        3. group Id
          BG004
          lower Limit
          61
          upper Limit
          69
          value
          68
        4. group Id
          BG005
          lower Limit
          53
          upper Limit
          74
          value
          68.5
        5. group Id
          BG006
          lower Limit
          37
          upper Limit
          74
          value
          67
    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
          10
        2. group Id
          BG003
          value
          7
        3. group Id
          BG004
          value
          2
        4. group Id
          BG005
          value
          5
        5. group Id
          BG006
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG003
          value
          5
        3. group Id
          BG004
          value
          3
        4. group Id
          BG005
          value
          19
        5. group Id
          BG006
          value
          53
        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
          1
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          4
        4. group Id
          BG005
          value
          23
        5. group Id
          BG006
          value
          74
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          1
        4. group Id
          BG005
          value
          1
        5. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          4
        5. group Id
          BG006
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          4
        4. group Id
          BG005
          value
          19
        5. group Id
          BG006
          value
          70
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          1
        5. group Id
          BG006
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          1
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          5
        4. group Id
          BG005
          value
          24
        5. group Id
          BG006
          value
          77
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      36
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      12
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      24
    7. group Id
      BG006
      value
      77
    units
    Participants
groups
  1. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG000
    title
    Arm A - Dose Level 1
  2. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG001
    title
    Arm A - Dose Level 2
  3. description
    Arm A - patients with MPD or MDS-RA/RARS Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG002
    title
    Arm A - Dose Level 3
  4. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 1 - 300 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG003
    title
    Arm B - Dose Level 1
  5. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 2 - 400 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG004
    title
    Arm B - Dose Level 2
  6. description
    Arm B - patients with MDS-RAEB or CMML Dose Level 3 - 450 cGy TBI NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. PBSC TRANSPLANTATION: Patients undergo filgrastim-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine PO BID on days -3 to 56, followed by a taper until day 180. Patients also receive MMF PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96.
    id
    BG005
    title
    Arm B - Dose Level 3
  7. description
    Total of all reporting groups
    id
    BG006
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          30
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          19
        7. group Id
          BG006
          value
          47
        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
          37
          upper Limit
          72
          value
          64.5
        2. group Id
          BG003
          lower Limit
          58
          upper Limit
          72
          value
          66.5
        3. group Id
          BG004
          lower Limit
          61
          upper Limit
          69
          value
          68
        4. group Id
          BG005
          lower Limit
          53
          upper Limit
          74
          value
          68.5
        5. group Id
          BG006
          lower Limit
          37
          upper Limit
          74
          value
          67
    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
          10
        2. group Id
          BG003
          value
          7
        3. group Id
          BG004
          value
          2
        4. group Id
          BG005
          value
          5
        5. group Id
          BG006
          value
          24
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG003
          value
          5
        3. group Id
          BG004
          value
          3
        4. group Id
          BG005
          value
          19
        5. group Id
          BG006
          value
          53
        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
          1
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          4
        4. group Id
          BG005
          value
          23
        5. group Id
          BG006
          value
          74
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          1
        4. group Id
          BG005
          value
          1
        5. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          4
        5. group Id
          BG006
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          4
        4. group Id
          BG005
          value
          19
        5. group Id
          BG006
          value
          70
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          0
        4. group Id
          BG005
          value
          1
        5. group Id
          BG006
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          0
        3. group Id
          BG004
          value
          1
        4. group Id
          BG005
          value
          0
        5. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG003
          value
          12
        3. group Id
          BG004
          value
          5
        4. group Id
          BG005
          value
          24
        5. group Id
          BG006
          value
          77
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
No patients were enrolled on arms A2 and A3 because dose escalation was never triggered.

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Preserved source evidence · Not medical advice