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NCT03105336 · BASELINE

Baseline characteristics

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

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
      124
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
    id
    BG000
    title
    Axicabtagene Ciloleucel (Follicular Lymphoma)
  2. description
    Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    BG001
    title
    Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          101
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          51
        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
          spread
          9.9
          value
          59
        2. group Id
          BG001
          spread
          9.6
          value
          63
        3. group Id
          BG002
          spread
          10.0
          value
          60.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          86
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          142
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          140
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other or More Than One Race
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Asian
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          142
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set was defined as all participants treated with any dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      124
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (IV) and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
    id
    BG000
    title
    Axicabtagene Ciloleucel (Follicular Lymphoma)
  2. description
    Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    BG001
    title
    Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          101
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          51
        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
          spread
          9.9
          value
          59
        2. group Id
          BG001
          spread
          9.6
          value
          63
        3. group Id
          BG002
          spread
          10.0
          value
          60.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          66
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          86
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          142
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          140
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other or More Than One Race
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Asian
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          142
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set was defined as all participants treated with any dose of study drug.

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Preserved source evidence · Not medical advice