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NCT03391466 · OUTCOME

Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index 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 Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.

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 Ciloleucel165
Standard of Care Therapy131

Reported measurements

Score at Baseline

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel165
Standard of Care Therapy131
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.8030.210Not reportedNot reportedNot reported
Standard of Care Therapy0.7990.250Not reportedNot reportedNot reported
Change from Baseline at Study Day 50

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel163
Standard of Care Therapy123
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel-0.0490.205Not reportedNot reportedNot reported
Standard of Care Therapy-0.0030.198Not reportedNot reportedNot reported
Change from Baseline at Study Day 100

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel146
Standard of Care Therapy65
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.0120.191Not reportedNot reportedNot reported
Standard of Care Therapy-0.0680.246Not 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 Ciloleucel0.0500.212Not reportedNot reportedNot reported
Standard of Care Therapy0.0140.208Not reportedNot reportedNot reported
Change from Baseline at Study Month 9

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel88
Standard of Care Therapy39
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.0640.190Not reportedNot reportedNot reported
Standard of Care Therapy0.0150.197Not reportedNot reportedNot reported
Change from Baseline at Study Month 12

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel79
Standard of Care Therapy32
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.0720.241Not reportedNot reportedNot reported
Standard of Care Therapy0.0510.200Not 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 Ciloleucel0.0510.209Not reportedNot reportedNot reported
Standard of Care Therapy0.0800.125Not reportedNot reportedNot reported
Change from Baseline at Study Month 18

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel71
Standard of Care Therapy22
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.0940.180Not reportedNot reportedNot reported
Standard of Care Therapy0.0720.188Not 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 Ciloleucel0.0890.235Not reportedNot reportedNot reported
Standard of Care Therapy0.1100.177Not reportedNot reportedNot reported
Change from Baseline at Study Month 24

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel33
Standard of Care Therapy12
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel0.0510.239Not reportedNot reportedNot reported
Standard of Care Therapy0.1170.138Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.024
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.138
    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
    0.0112
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    0.081
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    -0.034
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.091
    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
    0.3703
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    0.028
    statistical Method
    Mixed Model with Repeated Measures
Complete source fields
analyses
  1. ci Lower Limit
    0.024
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.138
    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
    0.0112
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    0.081
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    -0.034
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.091
    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
    0.3703
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    0.028
    statistical Method
    Mixed Model with Repeated Measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.210
        value
        0.803
      2. group Id
        OG001
        spread
        0.250
        value
        0.799
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        131
      units
      Participants
    title
    Score at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.205
        value
        -0.049
      2. group Id
        OG001
        spread
        0.198
        value
        -0.003
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        123
      units
      Participants
    title
    Change from Baseline at Study Day 50
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.191
        value
        0.012
      2. group Id
        OG001
        spread
        0.246
        value
        -0.068
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Change from Baseline at Study Day 100
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.212
        value
        0.050
      2. group Id
        OG001
        spread
        0.208
        value
        0.014
    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
        0.190
        value
        0.064
      2. group Id
        OG001
        spread
        0.197
        value
        0.015
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    Change from Baseline at Study Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.241
        value
        0.072
      2. group Id
        OG001
        spread
        0.200
        value
        0.051
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Change from Baseline at Study Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.209
        value
        0.051
      2. group Id
        OG001
        spread
        0.125
        value
        0.080
    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
        0.180
        value
        0.094
      2. group Id
        OG001
        spread
        0.188
        value
        0.072
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Change from Baseline at Study Month 18
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.235
        value
        0.089
      2. group Id
        OG001
        spread
        0.177
        value
        0.110
    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
        0.239
        value
        0.051
      2. group Id
        OG001
        spread
        0.138
        value
        0.117
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      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
      131
    units
    Participants
description
The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.
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
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
type
SECONDARY
unit Of Measure
Score on scale

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

Preserved source evidence · Not medical advice