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NCT02601313 · BASELINE

Baseline characteristics

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18

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
      10
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      92
    units
    Participants
groups
  1. description
    Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG000
    title
    2 x 10^6 Axicabtagene Ciloleucel
  2. description
    Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
    id
    BG001
    title
    Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
  3. description
    Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
    id
    BG002
    title
    Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          44
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          48
      title
      >= 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          77
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          76
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          85
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Others
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          86
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The Safety Analysis Set included all participants treated with any dose of anti-CD19 CAR T cells.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    2. group Id
      BG001
      value
      68
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      92
    units
    Participants
groups
  1. description
    Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG000
    title
    2 x 10^6 Axicabtagene Ciloleucel
  2. description
    Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
    id
    BG001
    title
    Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
  3. description
    Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
    id
    BG002
    title
    Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          44
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          48
      title
      >= 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          77
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          76
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          85
        title
        White
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Native Hawaiian or other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        title
        Others
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          86
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      France
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Germany
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The Safety Analysis Set included all participants treated with any dose of anti-CD19 CAR T cells.

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

Preserved source evidence · Not medical advice