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NCT00719888 · BASELINE

Baseline characteristics

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease · Source last updated 2025-03-07

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
      108
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      135
    units
    Participants
groups
  1. description
    Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord)
    id
    BG000
    title
    Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide
  2. description
    Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord) Thiotepa: Given IV
    id
    BG001
    title
    Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          66
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          69
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
          upper Limit
          45
          value
          22
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          63
          value
          24.5
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          63
          value
          22.5
    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
          45
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          59
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          76
        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
          4
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          85
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      108
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      135
    units
    Participants
groups
  1. description
    Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord)
    id
    BG000
    title
    Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide
  2. description
    Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord) Thiotepa: Given IV
    id
    BG001
    title
    Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          66
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          69
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
          upper Limit
          45
          value
          22
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          63
          value
          24.5
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          63
          value
          22.5
    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
          45
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          59
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          76
        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
          4
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          85
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          17
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice