Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas · Source last updated 2025-08-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
baseline, months 1, 6, 9, 12, 18, 24, 36
What was measured
Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
Analysis population: All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point
Groups in this outcome
Standard of Care Arm
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Liso-cel Arm
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
41
Liso-cel Arm
43
Reported measurements
Global Health/Quality of Life Month 1
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
41
Liso-cel Arm
43
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-9.55
25.655
Not reported
Not reported
Not reported
Liso-cel Arm
-5.23
18.004
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 6
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
15
Liso-cel Arm
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-2.78
24.734
Not reported
Not reported
Not reported
Liso-cel Arm
12.36
23.635
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 9
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
11
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
5.30
24.516
Not reported
Not reported
Not reported
Liso-cel Arm
12.50
22.252
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 12
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
8
Liso-cel Arm
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
15.63
32.865
Not reported
Not reported
Not reported
Liso-cel Arm
8.93
24.525
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 18
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
9
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
14.81
29.397
Not reported
Not reported
Not reported
Liso-cel Arm
8.33
23.442
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 24
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
12.50
28.934
Not reported
Not reported
Not reported
Liso-cel Arm
7.29
23.093
Not reported
Not reported
Not reported
Global Health/Quality of Life Month 36
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
15.00
21.802
Not reported
Not reported
Not reported
Liso-cel Arm
2.67
21.071
Not reported
Not reported
Not reported
Physical Functioning Month 1
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
41
Liso-cel Arm
43
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-8.94
19.867
Not reported
Not reported
Not reported
Liso-cel Arm
-4.03
16.339
Not reported
Not reported
Not reported
Physical Functioning Month 6
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
16
Liso-cel Arm
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-2.08
11.081
Not reported
Not reported
Not reported
Liso-cel Arm
2.24
17.470
Not reported
Not reported
Not reported
Physical Functioning Month 9
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
11
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
0.61
9.167
Not reported
Not reported
Not reported
Liso-cel Arm
5.00
21.825
Not reported
Not reported
Not reported
Physical Functioning Month 12
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
8
Liso-cel Arm
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
10.00
17.817
Not reported
Not reported
Not reported
Liso-cel Arm
4.52
17.875
Not reported
Not reported
Not reported
Physical Functioning Month 18
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
9
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
13.33
22.608
Not reported
Not reported
Not reported
Liso-cel Arm
1.73
17.027
Not reported
Not reported
Not reported
Physical Functioning Month 24
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
10.67
18.645
Not reported
Not reported
Not reported
Liso-cel Arm
2.78
22.147
Not reported
Not reported
Not reported
Physical Functioning Month 36
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
7.33
15.540
Not reported
Not reported
Not reported
Liso-cel Arm
-1.87
16.613
Not reported
Not reported
Not reported
Cognitive Functioning Month 1
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
41
Liso-cel Arm
43
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-8.54
19.047
Not reported
Not reported
Not reported
Liso-cel Arm
-0.39
16.462
Not reported
Not reported
Not reported
Cognitive Functioning Month 6
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
15
Liso-cel Arm
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-3.33
14.365
Not reported
Not reported
Not reported
Liso-cel Arm
3.45
20.596
Not reported
Not reported
Not reported
Cognitive Functioning Month 9
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
11
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-3.03
16.361
Not reported
Not reported
Not reported
Liso-cel Arm
9.72
23.008
Not reported
Not reported
Not reported
Cognitive Functioning Month 12
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
8
Liso-cel Arm
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-4.17
7.715
Not reported
Not reported
Not reported
Liso-cel Arm
4.17
27.074
Not reported
Not reported
Not reported
Cognitive Functioning Month 18
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
9
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
0.00
18.634
Not reported
Not reported
Not reported
Liso-cel Arm
4.17
26.580
Not reported
Not reported
Not reported
Cognitive Functioning Month 24
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
0.00
13.608
Not reported
Not reported
Not reported
Liso-cel Arm
0.00
26.919
Not reported
Not reported
Not reported
Cognitive Functioning Month 36
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-1.67
9.461
Not reported
Not reported
Not reported
Liso-cel Arm
2.67
17.795
Not reported
Not reported
Not reported
Fatigue Month 1
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
41
Liso-cel Arm
43
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
19.24
24.848
Not reported
Not reported
Not reported
Liso-cel Arm
0.26
20.501
Not reported
Not reported
Not reported
Fatigue Month 6
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
16
Liso-cel Arm
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
0.69
27.657
Not reported
Not reported
Not reported
Liso-cel Arm
-12.84
29.811
Not reported
Not reported
Not reported
Fatigue Month 9
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
11
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-4.04
29.090
Not reported
Not reported
Not reported
Liso-cel Arm
-10.65
36.702
Not reported
Not reported
Not reported
Fatigue Month 12
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
8
Liso-cel Arm
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-6.94
8.267
Not reported
Not reported
Not reported
Liso-cel Arm
-9.52
33.363
Not reported
Not reported
Not reported
Fatigue Month 18
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
9
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-6.17
22.299
Not reported
Not reported
Not reported
Liso-cel Arm
-10.22
30.919
Not reported
Not reported
Not reported
Fatigue Month 24
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-6.67
19.030
Not reported
Not reported
Not reported
Liso-cel Arm
-8.80
30.557
Not reported
Not reported
Not reported
Fatigue Month 36
Analysis denominator · Participants
Group
Source count
Standard of Care Arm
10
Liso-cel Arm
25
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Standard of Care Arm
-3.33
16.605
Not reported
Not reported
Not reported
Liso-cel Arm
-5.33
25.884
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
25.655
value
-9.55
group Id
OG001
spread
18.004
value
-5.23
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
43
units
Participants
title
Global Health/Quality of Life Month 1
categories
measurements
group Id
OG000
spread
24.734
value
-2.78
group Id
OG001
spread
23.635
value
12.36
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
29
units
Participants
title
Global Health/Quality of Life Month 6
categories
measurements
group Id
OG000
spread
24.516
value
5.30
group Id
OG001
spread
22.252
value
12.50
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
24
units
Participants
title
Global Health/Quality of Life Month 9
categories
measurements
group Id
OG000
spread
32.865
value
15.63
group Id
OG001
spread
24.525
value
8.93
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
28
units
Participants
title
Global Health/Quality of Life Month 12
categories
measurements
group Id
OG000
spread
29.397
value
14.81
group Id
OG001
spread
23.442
value
8.33
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
24
units
Participants
title
Global Health/Quality of Life Month 18
categories
measurements
group Id
OG000
spread
28.934
value
12.50
group Id
OG001
spread
23.093
value
7.29
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
24
units
Participants
title
Global Health/Quality of Life Month 24
categories
measurements
group Id
OG000
spread
21.802
value
15.00
group Id
OG001
spread
21.071
value
2.67
denoms
counts
group Id
OG000
value
10
group Id
OG001
value
25
units
Participants
title
Global Health/Quality of Life Month 36
categories
measurements
group Id
OG000
spread
19.867
value
-8.94
group Id
OG001
spread
16.339
value
-4.03
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
43
units
Participants
title
Physical Functioning Month 1
categories
measurements
group Id
OG000
spread
11.081
value
-2.08
group Id
OG001
spread
17.470
value
2.24
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
29
units
Participants
title
Physical Functioning Month 6
categories
measurements
group Id
OG000
spread
9.167
value
0.61
group Id
OG001
spread
21.825
value
5.00
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
24
units
Participants
title
Physical Functioning Month 9
categories
measurements
group Id
OG000
spread
17.817
value
10.00
group Id
OG001
spread
17.875
value
4.52
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
28
units
Participants
title
Physical Functioning Month 12
categories
measurements
group Id
OG000
spread
22.608
value
13.33
group Id
OG001
spread
17.027
value
1.73
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
25
units
Participants
title
Physical Functioning Month 18
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
43
units
Participants
description
Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
dispersion Type
Standard Deviation
groups
description
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
id
OG000
title
Standard of Care Arm
description
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
id
OG001
title
Liso-cel Arm
param Type
MEAN
population Description
All treated participants with a health-related quality of life baseline assessment value and a post-baseline value at the time point
reporting Status
POSTED
time Frame
baseline, months 1, 6, 9, 12, 18, 24, 36
title
Change From Baseline in the European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
Triangle