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NCT03391466 · OUTCOME

Change From Baseline in Global Health Status Scores

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Score on scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24

What was measured

Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.

Analysis population: Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.

Groups in this outcome

Axicabtagene Ciloleucel

Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Standard of Care Therapy

Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel165
Standard of Care Therapy130

Reported measurements

Score at Baseline

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel165
Standard of Care Therapy130
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel68.619.9Not reportedNot reportedNot reported
Standard of Care Therapy70.123.1Not reportedNot reportedNot reported
Change from Baseline at Study Day 50

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel163
Standard of Care Therapy124
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel-7.420.2Not reportedNot reportedNot reported
Standard of Care Therapy-8.522.7Not reportedNot reportedNot reported
Change from Baseline at Study Day 100

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel146
Standard of Care Therapy62
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel1.319.6Not reportedNot reportedNot reported
Standard of Care Therapy-15.322.7Not reportedNot reportedNot reported
Change from Baseline at Study Day 150

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel110
Standard of Care Therapy56
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel5.924.9Not reportedNot reportedNot reported
Standard of Care Therapy-4.223.7Not reportedNot reportedNot reported
Change from Baseline at Study Month 9

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel88
Standard of Care Therapy40
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel8.022.7Not reportedNot reportedNot reported
Standard of Care Therapy3.523.7Not reportedNot reportedNot reported
Change from Baseline at Study Month 12

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel79
Standard of Care Therapy33
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel8.624.9Not reportedNot reportedNot reported
Standard of Care Therapy9.120.2Not reportedNot reportedNot reported
Change from Baseline at Study Month 15

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel67
Standard of Care Therapy26
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel9.022.3Not reportedNot reportedNot reported
Standard of Care Therapy9.918.9Not reportedNot reportedNot reported
Change from Baseline at Study Month 18

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel71
Standard of Care Therapy23
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel10.220.9Not reportedNot reportedNot reported
Standard of Care Therapy6.521.3Not reportedNot reportedNot reported
Change from Baseline at Study Month 21

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel45
Standard of Care Therapy20
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel10.021.5Not reportedNot reportedNot reported
Standard of Care Therapy15.019.6Not reportedNot reportedNot reported
Change from Baseline at Study Month 24

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel32
Standard of Care Therapy12
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel8.621.0Not reportedNot reportedNot reported
Standard of Care Therapy13.217.2Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    12.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.9
    group Description
    Difference in mean change of scores from Baseline at Day 100.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    18.1
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    2.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.0
    group Description
    Difference in mean change of scores from Baseline at Day 150.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0124
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    9.8
    statistical Method
    Mixed Model with Repeated Measures
  3. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.0
    group Description
    Difference in mean change of scores from Baseline at Month 9.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2655
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    4.4
    statistical Method
    Mixed Model with Repeated Measures
Complete source fields
analyses
  1. ci Lower Limit
    12.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.9
    group Description
    Difference in mean change of scores from Baseline at Day 100.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    18.1
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    2.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.0
    group Description
    Difference in mean change of scores from Baseline at Day 150.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0124
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    9.8
    statistical Method
    Mixed Model with Repeated Measures
  3. ci Lower Limit
    -3.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.0
    group Description
    Difference in mean change of scores from Baseline at Month 9.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2655
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    4.4
    statistical Method
    Mixed Model with Repeated Measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.9
        value
        68.6
      2. group Id
        OG001
        spread
        23.1
        value
        70.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        130
      units
      Participants
    title
    Score at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.2
        value
        -7.4
      2. group Id
        OG001
        spread
        22.7
        value
        -8.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        124
      units
      Participants
    title
    Change from Baseline at Study Day 50
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.6
        value
        1.3
      2. group Id
        OG001
        spread
        22.7
        value
        -15.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        62
      units
      Participants
    title
    Change from Baseline at Study Day 100
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.9
        value
        5.9
      2. group Id
        OG001
        spread
        23.7
        value
        -4.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Change from Baseline at Study Day 150
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.7
        value
        8.0
      2. group Id
        OG001
        spread
        23.7
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        40
      units
      Participants
    title
    Change from Baseline at Study Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.9
        value
        8.6
      2. group Id
        OG001
        spread
        20.2
        value
        9.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    Change from Baseline at Study Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.3
        value
        9.0
      2. group Id
        OG001
        spread
        18.9
        value
        9.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    Change from Baseline at Study Month 15
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.9
        value
        10.2
      2. group Id
        OG001
        spread
        21.3
        value
        6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Change from Baseline at Study Month 18
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.5
        value
        10.0
      2. group Id
        OG001
        spread
        19.6
        value
        15.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Change from Baseline at Study Month 21
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.0
        value
        8.6
      2. group Id
        OG001
        spread
        17.2
        value
        13.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Change from Baseline at Study Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      130
    units
    Participants
description
Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    OG000
    title
    Axicabtagene Ciloleucel
  2. description
    Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
    id
    OG001
    title
    Standard of Care Therapy
param Type
MEAN
population Description
Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.
reporting Status
POSTED
time Frame
Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24
title
Change From Baseline in Global Health Status Scores
type
SECONDARY
unit Of Measure
Score on scale

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

Preserved source evidence · Not medical advice