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NCT03575351 · OUTCOME

Change From Baseline in Selected Hematology Parameters 2

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: 10^9 cells/L
Interval / dispersion: Standard Deviation
Time frame: baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

What was measured

Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. 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 baseline 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	73
Liso-cel Arm	84

Reported measurements

Month 1 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	73
Liso-cel Arm	84

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.815	6.9413	Not reported	Not reported	Not reported
Liso-cel Arm	-3.219	2.4688	Not reported	Not reported	Not reported

Month 2 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.870	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	41
Liso-cel Arm	72

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-3.445	5.8845	Not reported	Not reported	Not reported
Liso-cel Arm	-2.234	2.3520	Not reported	Not reported	Not reported

Month 4 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.180	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	30
Liso-cel Arm	62

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.699	1.9099	Not reported	Not reported	Not reported
Liso-cel Arm	-1.853	2.5876	Not reported	Not reported	Not reported

Month 9 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	22
Liso-cel Arm	60

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.710	3.0670	Not reported	Not reported	Not reported
Liso-cel Arm	-1.156	3.3604	Not reported	Not reported	Not reported

Month 12 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	59

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.427	1.4093	Not reported	Not reported	Not reported
Liso-cel Arm	-1.138	2.3772	Not reported	Not reported	Not reported

Month 18 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	52

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.598	1.6136	Not reported	Not reported	Not reported
Liso-cel Arm	-1.088	2.8028	Not reported	Not reported	Not reported

Month 24 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	45

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.694	3.0465	Not reported	Not reported	Not reported
Liso-cel Arm	-0.806	2.5709	Not reported	Not reported	Not reported

Month 36 leukocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	41

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.761	2.3637	Not reported	Not reported	Not reported
Liso-cel Arm	-0.970	3.0158	Not reported	Not reported	Not reported

Month 1 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	73
Liso-cel Arm	83

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.2824	0.43519	Not reported	Not reported	Not reported
Liso-cel Arm	-0.7380	0.43499	Not reported	Not reported	Not reported

Month 2 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.2100	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	71

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.4216	0.55872	Not reported	Not reported	Not reported
Liso-cel Arm	-0.1318	0.43385	Not reported	Not reported	Not reported

Month 4 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.1700	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	30
Liso-cel Arm	62

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.1343	0.38219	Not reported	Not reported	Not reported
Liso-cel Arm	-0.0845	0.48047	Not reported	Not reported	Not reported

Month 9 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	22
Liso-cel Arm	60

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.3264	0.66121	Not reported	Not reported	Not reported
Liso-cel Arm	-0.0442	0.39684	Not reported	Not reported	Not reported

Month 12 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	59

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.5089	0.71831	Not reported	Not reported	Not reported
Liso-cel Arm	0.0097	0.37252	Not reported	Not reported	Not reported

Month 18 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	52

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.6942	0.98993	Not reported	Not reported	Not reported
Liso-cel Arm	0.2283	0.55421	Not reported	Not reported	Not reported

Month 24 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	45

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.8688	1.12695	Not reported	Not reported	Not reported
Liso-cel Arm	0.3298	0.51386	Not reported	Not reported	Not reported

Month 36 lymphocytes

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	40

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	1.2253	1.20268	Not reported	Not reported	Not reported
Liso-cel Arm	0.3550	0.55387	Not reported	Not reported	Not reported

Month 1 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	73
Liso-cel Arm	83

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	1.368	6.5393	Not reported	Not reported	Not reported
Liso-cel Arm	-2.065	2.3479	Not reported	Not reported	Not reported

Month 2 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.590	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	71

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.621	6.8377	Not reported	Not reported	Not reported
Liso-cel Arm	-1.909	2.1727	Not reported	Not reported	Not reported

Month 4 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.160	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	30
Liso-cel Arm	62

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.648	1.7635	Not reported	Not reported	Not reported
Liso-cel Arm	-1.584	2.4539	Not reported	Not reported	Not reported

Month 9 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	22
Liso-cel Arm	60

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.879	2.9777	Not reported	Not reported	Not reported
Liso-cel Arm	-1.001	3.1318	Not reported	Not reported	Not reported

Month 12 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	59

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.822	1.5780	Not reported	Not reported	Not reported
Liso-cel Arm	-1.035	2.2898	Not reported	Not reported	Not reported

Month 18 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	52

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.167	1.3772	Not reported	Not reported	Not reported
Liso-cel Arm	-1.189	2.6342	Not reported	Not reported	Not reported

Month 24 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	45

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.124	2.5434	Not reported	Not reported	Not reported
Liso-cel Arm	-0.998	2.5506	Not reported	Not reported	Not reported

Month 36 neutrophils

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	40

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.404	1.8392	Not reported	Not reported	Not reported
Liso-cel Arm	-0.998	2.5222	Not reported	Not reported	Not reported

Month 1 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	72
Liso-cel Arm	78

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	13.9	140.94	Not reported	Not reported	Not reported
Liso-cel Arm	29.4	115.53	Not reported	Not reported	Not reported

Month 2 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	13.0	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	38
Liso-cel Arm	71

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-189.5	132.93	Not reported	Not reported	Not reported
Liso-cel Arm	-65.7	100.52	Not reported	Not reported	Not reported

Month 4 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	1
Liso-cel Arm	0

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-74.0	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	30
Liso-cel Arm	60

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-45.5	94.13	Not reported	Not reported	Not reported
Liso-cel Arm	-48.2	89.04	Not reported	Not reported	Not reported

Month 9 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	22
Liso-cel Arm	58

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-57.0	110.48	Not reported	Not reported	Not reported
Liso-cel Arm	-48.9	89.29	Not reported	Not reported	Not reported

Month 12 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	56

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-66.5	85.82	Not reported	Not reported	Not reported
Liso-cel Arm	-42.4	92.65	Not reported	Not reported	Not reported

Month 18 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	19
Liso-cel Arm	52

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-68.0	84.69	Not reported	Not reported	Not reported
Liso-cel Arm	-32.6	81.68	Not reported	Not reported	Not reported

Month 24 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	44

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-29.4	103.87	Not reported	Not reported	Not reported
Liso-cel Arm	-28.7	79.70	Not reported	Not reported	Not reported

Month 36 platelets

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	17
Liso-cel Arm	40

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-45.2	123.28	Not reported	Not reported	Not reported
Liso-cel Arm	-10.5	72.79	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
6.9413
value
0.815
group Id
OG001
spread
2.4688
value
-3.219
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
84
units
Participants
title
Month 1 leukocytes
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-0.870
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 leukocytes
categories
measurements
group Id
OG000
spread
5.8845
value
-3.445
group Id
OG001
spread
2.3520
value
-2.234
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
72
units
Participants
title
Month 3 leukocytes
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-1.180
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 4 leukocytes
categories
measurements
group Id
OG000
spread
1.9099
value
-1.699
group Id
OG001
spread
2.5876
value
-1.853
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
62
units
Participants
title
Month 6 leukocytes
categories
measurements
group Id
OG000
spread
3.0670
value
-0.710
group Id
OG001
spread
3.3604
value
-1.156
denoms
counts
group Id
OG000
value
22
group Id
OG001
value
60
units
Participants
title
Month 9 leukocytes
categories
measurements
group Id
OG000
spread
1.4093
value
-0.427
group Id
OG001
spread
2.3772
value
-1.138
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
59
units
Participants
title
Month 12 leukocytes
categories
measurements
group Id
OG000
spread
1.6136
value
-0.598
group Id
OG001
spread
2.8028
value
-1.088
denoms
counts
group Id
OG000
value
19
group Id
OG001
value
52
units
Participants
title
Month 18 leukocytes
categories
measurements
group Id
OG000
spread
3.0465
value
0.694
group Id
OG001
spread
2.5709
value
-0.806
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
45
units
Participants
title
Month 24 leukocytes
categories
measurements
group Id
OG000
spread
2.3637
value
0.761
group Id
OG001
spread
3.0158
value
-0.970
denoms
counts
group Id
OG000
value
17
group Id
OG001
value
41
units
Participants
title
Month 36 leukocytes
categories
measurements
group Id
OG000
spread
0.43519
value
-0.2824
group Id
OG001
spread
0.43499
value
-0.7380
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
83
units
Participants
title
Month 1 lymphocytes
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-0.2100
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 lymphocytes

denoms

counts
group Id
OG000
value
73
group Id
OG001
value
84
units
Participants

description

Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. 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 baseline value and a post-baseline value at the time point

reporting Status

POSTED

time Frame

baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36

title

Change From Baseline in Selected Hematology Parameters 2

type

SECONDARY

unit Of Measure

10^9 cells/L

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Preserved source evidence · Not medical advice