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NCT03391466 · OUTCOME

Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

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, 150, Months 9, 12, 15, 18, 21 and 24

What was measured

The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.

Analysis population: Participants in QoL analysis set with data available at given timepoint were analyzed.

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 Ciloleucel164
Standard of Care Therapy131

Reported measurements

Score at Baseline

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel164
Standard of Care Therapy131
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel83.517.7Not reportedNot reportedNot reported
Standard of Care Therapy85.318.9Not reportedNot reportedNot reported
Change from Baseline at Study Day 50

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel162
Standard of Care Therapy126
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel-12.921.7Not reportedNot reportedNot reported
Standard of Care Therapy-8.317.5Not reportedNot reportedNot reported
Change from Baseline at Study Day 100

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel146
Standard of Care Therapy64
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel-1.817.8Not reportedNot reportedNot reported
Standard of Care Therapy-15.019.1Not reportedNot reportedNot reported
Change from Baseline at Study Day 150

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel109
Standard of Care Therapy56
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel1.318.9Not reportedNot reportedNot reported
Standard of Care Therapy-5.221.3Not 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 Ciloleucel4.117.1Not reportedNot reportedNot reported
Standard of Care Therapy-2.423.5Not 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 Ciloleucel3.420.8Not reportedNot reportedNot reported
Standard of Care Therapy0.420.3Not 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 Ciloleucel3.919.3Not reportedNot reportedNot reported
Standard of Care Therapy1.616.1Not 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 Ciloleucel5.015.1Not reportedNot reportedNot reported
Standard of Care Therapy3.217.9Not 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 Ciloleucel6.016.1Not reportedNot reportedNot reported
Standard of Care Therapy4.321.4Not 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 Ciloleucel3.716.5Not reportedNot reportedNot reported
Standard of Care Therapy5.68.0Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    8.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.2
    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
    13.1
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.0
    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
    0.1253
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    5.1
    statistical Method
    Mixed Model with Repeated Measures
Complete source fields
analyses
  1. ci Lower Limit
    8.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.2
    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
    13.1
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.0
    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
    0.1253
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    5.1
    statistical Method
    Mixed Model with Repeated Measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.7
        value
        83.5
      2. group Id
        OG001
        spread
        18.9
        value
        85.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    Score at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.7
        value
        -12.9
      2. group Id
        OG001
        spread
        17.5
        value
        -8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        162
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    Change from Baseline at Study Day 50
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.8
        value
        -1.8
      2. group Id
        OG001
        spread
        19.1
        value
        -15.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    Change from Baseline at Study Day 100
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.9
        value
        1.3
      2. group Id
        OG001
        spread
        21.3
        value
        -5.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      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
        17.1
        value
        4.1
      2. group Id
        OG001
        spread
        23.5
        value
        -2.4
    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
        20.8
        value
        3.4
      2. group Id
        OG001
        spread
        20.3
        value
        0.4
    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
        19.3
        value
        3.9
      2. group Id
        OG001
        spread
        16.1
        value
        1.6
    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
        15.1
        value
        5.0
      2. group Id
        OG001
        spread
        17.9
        value
        3.2
    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
        16.1
        value
        6.0
      2. group Id
        OG001
        spread
        21.4
        value
        4.3
    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
        16.5
        value
        3.7
      2. group Id
        OG001
        spread
        8.0
        value
        5.6
    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
      164
    2. group Id
      OG001
      value
      131
    units
    Participants
description
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.
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 QoL analysis set with data available at given timepoint were analyzed.
reporting Status
POSTED
time Frame
Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24
title
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
type
SECONDARY
unit Of Measure
Score on scale

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

Preserved source evidence · Not medical advice