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NCT02028455 · BASELINE

Baseline characteristics

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia · Source last updated 2026-08-06

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
      7
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      120
    9. group Id
      BG008
      value
      167
    units
    Participants
groups
  1. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
    id
    BG000
    title
    Phase 1-Cohort 1A
  2. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
    id
    BG001
    title
    Phase 1-Cohort 1B
  3. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
    id
    BG002
    title
    Phase 1-Cohort 1C
  4. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
    id
    BG003
    title
    Phase 1-Cohort 1D
  5. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    BG004
    title
    Phase 1-Cohort 1F1
  6. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    BG005
    title
    Phase 1-Cohort 1F2
  7. description
    This phase 1 cohort did not receive Patient Derived CD19 specific CAR T cells
    id
    BG006
    title
    Phase 1 - Not Treated
  8. description
    The phase 2 cohort received Patient Derived CD19 specific CAR T cells following lymphodepletion if indicated
    id
    BG007
    title
    Phase 2
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          22
          value
          19
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          23
          value
          9
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          20
          value
          15
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          22
          value
          6
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          25
          value
          10
        6. group Id
          BG005
          lower Limit
          4
          upper Limit
          21
          value
          13.5
        7. group Id
          BG006
          lower Limit
          8
          upper Limit
          14
          value
          11
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          26
          value
          13
        9. group Id
          BG008
          lower Limit
          1
          upper Limit
          26
          value
          13
    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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          40
        9. group Id
          BG008
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          80
        9. group Id
          BG008
          value
          104
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          38
        9. group Id
          BG008
          value
          49
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          72
        9. group Id
          BG008
          value
          105
        title
        Not Hispanic or Latino
      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
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          13
        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
          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
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          10
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          66
        9. group Id
          BG008
          value
          96
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          39
        9. group Id
          BG008
          value
          49
        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
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          106
        9. group Id
          BG008
          value
          153
      title
      Leukemia
    2. 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
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          14
      title
      Non Hodgkin's Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      120
    9. group Id
      BG008
      value
      167
    units
    Participants
groups
  1. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
    id
    BG000
    title
    Phase 1-Cohort 1A
  2. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
    id
    BG001
    title
    Phase 1-Cohort 1B
  3. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
    id
    BG002
    title
    Phase 1-Cohort 1C
  4. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
    id
    BG003
    title
    Phase 1-Cohort 1D
  5. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    BG004
    title
    Phase 1-Cohort 1F1
  6. description
    This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
    id
    BG005
    title
    Phase 1-Cohort 1F2
  7. description
    This phase 1 cohort did not receive Patient Derived CD19 specific CAR T cells
    id
    BG006
    title
    Phase 1 - Not Treated
  8. description
    The phase 2 cohort received Patient Derived CD19 specific CAR T cells following lymphodepletion if indicated
    id
    BG007
    title
    Phase 2
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          22
          value
          19
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          23
          value
          9
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          20
          value
          15
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          22
          value
          6
        5. group Id
          BG004
          lower Limit
          1
          upper Limit
          25
          value
          10
        6. group Id
          BG005
          lower Limit
          4
          upper Limit
          21
          value
          13.5
        7. group Id
          BG006
          lower Limit
          8
          upper Limit
          14
          value
          11
        8. group Id
          BG007
          lower Limit
          1
          upper Limit
          26
          value
          13
        9. group Id
          BG008
          lower Limit
          1
          upper Limit
          26
          value
          13
    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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          40
        9. group Id
          BG008
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          80
        9. group Id
          BG008
          value
          104
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          38
        9. group Id
          BG008
          value
          49
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          72
        9. group Id
          BG008
          value
          105
        title
        Not Hispanic or Latino
      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
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          13
        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
          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
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          10
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          66
        9. group Id
          BG008
          value
          96
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          39
        9. group Id
          BG008
          value
          49
        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
          7
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          106
        9. group Id
          BG008
          value
          153
      title
      Leukemia
    2. 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
        8. group Id
          BG007
          value
          14
        9. group Id
          BG008
          value
          14
      title
      Non Hodgkin's Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Diagnosis
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice