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NCT01119066 · BASELINE

Baseline characteristics

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies · Source last updated 2022-08-05

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
      125
    2. group Id
      BG001
      value
      213
    3. group Id
      BG002
      value
      52
    4. group Id
      BG003
      value
      11
    5. group Id
      BG004
      value
      401
    units
    Participants
groups
  1. description
    Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG000
    title
    Total Body Irradiation, Thiotepa and Cyclophosphamide
  2. description
    Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG001
    title
    Busulfan, Melphalan and Fludarabine
  3. description
    Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG002
    title
    Clofarabine, Melphalan and Thiotepa
  4. description
    Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG003
    title
    Melphalan, Fludarabine and Thiotepa
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3.5
          upper Limit
          63.9
          value
          30.3
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          73
          value
          57.6
        3. group Id
          BG002
          lower Limit
          0.6
          upper Limit
          67.2
          value
          28.1
        4. group Id
          BG003
          lower Limit
          0.8
          upper Limit
          67.2
          value
          10
        5. group Id
          BG004
          lower Limit
          0.6
          upper Limit
          73
          value
          48
    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
          63
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          221
        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
          18
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          244
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          119
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          29
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          33
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          317
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          401
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      125
    2. group Id
      BG001
      value
      213
    3. group Id
      BG002
      value
      52
    4. group Id
      BG003
      value
      11
    5. group Id
      BG004
      value
      401
    units
    Participants
groups
  1. description
    Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG000
    title
    Total Body Irradiation, Thiotepa and Cyclophosphamide
  2. description
    Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG001
    title
    Busulfan, Melphalan and Fludarabine
  3. description
    Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG002
    title
    Clofarabine, Melphalan and Thiotepa
  4. description
    Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant
    id
    BG003
    title
    Melphalan, Fludarabine and Thiotepa
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3.5
          upper Limit
          63.9
          value
          30.3
        2. group Id
          BG001
          lower Limit
          2
          upper Limit
          73
          value
          57.6
        3. group Id
          BG002
          lower Limit
          0.6
          upper Limit
          67.2
          value
          28.1
        4. group Id
          BG003
          lower Limit
          0.8
          upper Limit
          67.2
          value
          10
        5. group Id
          BG004
          lower Limit
          0.6
          upper Limit
          73
          value
          48
    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
          63
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          221
        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
          18
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          244
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          119
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          29
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          33
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          41
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          317
        title
        White
      6. 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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          21
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          401
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice