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NCT03575351 · OUTCOME

Change From Baseline in Selected Chemistry 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: mmol/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 chemistry parameters such as magnesium, phosphate, potassium, and sodium. 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	76
Liso-cel Arm	88

Reported measurements

Month 1 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	76
Liso-cel Arm	88

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.023	0.1145	Not reported	Not reported	Not reported
Liso-cel Arm	0.009	0.0933	Not reported	Not reported	Not reported

Month 2 magnesium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.080	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	44
Liso-cel Arm	73

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.063	0.1210	Not reported	Not reported	Not reported
Liso-cel Arm	0.007	0.1010	Not reported	Not reported	Not reported

Month 4 magnesium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.200	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	31
Liso-cel Arm	66

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.041	0.1452	Not reported	Not reported	Not reported
Liso-cel Arm	0.015	0.1090	Not reported	Not reported	Not reported

Month 9 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	23
Liso-cel Arm	62

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.027	0.1459	Not reported	Not reported	Not reported
Liso-cel Arm	0.025	0.1079	Not reported	Not reported	Not reported

Month 12 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	58

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.012	0.1047	Not reported	Not reported	Not reported
Liso-cel Arm	0.031	0.1054	Not reported	Not reported	Not reported

Month 18 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	20
Liso-cel Arm	54

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.033	0.0639	Not reported	Not reported	Not reported
Liso-cel Arm	0.032	0.1065	Not reported	Not reported	Not reported

Month 24 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	16
Liso-cel Arm	48

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.040	0.1145	Not reported	Not reported	Not reported
Liso-cel Arm	0.015	0.1027	Not reported	Not reported	Not reported

Month 36 magnesium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	41

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.039	0.0920	Not reported	Not reported	Not reported
Liso-cel Arm	0.011	0.0751	Not reported	Not reported	Not reported

Month 1 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	76
Liso-cel Arm	88

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.061	0.2643	Not reported	Not reported	Not reported
Liso-cel Arm	-0.038	0.2498	Not reported	Not reported	Not reported

Month 2 phosphate

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.030	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	44
Liso-cel Arm	74

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.128	0.3299	Not reported	Not reported	Not reported
Liso-cel Arm	0.039	0.2316	Not reported	Not reported	Not reported

Month 4 phosphate

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.130	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	31
Liso-cel Arm	66

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.140	0.2166	Not reported	Not reported	Not reported
Liso-cel Arm	-0.020	0.2276	Not reported	Not reported	Not reported

Month 9 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	23
Liso-cel Arm	62

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.025	0.2020	Not reported	Not reported	Not reported
Liso-cel Arm	-0.028	0.2098	Not reported	Not reported	Not reported

Month 12 phosphate

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.021	0.1578	Not reported	Not reported	Not reported
Liso-cel Arm	-0.090	0.2051	Not reported	Not reported	Not reported

Month 18 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	20
Liso-cel Arm	54

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.025	0.2666	Not reported	Not reported	Not reported
Liso-cel Arm	-0.059	0.2224	Not reported	Not reported	Not reported

Month 24 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	16
Liso-cel Arm	48

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.064	0.2469	Not reported	Not reported	Not reported
Liso-cel Arm	-0.061	0.2549	Not reported	Not reported	Not reported

Month 36 phosphate

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	41

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.044	0.2464	Not reported	Not reported	Not reported
Liso-cel Arm	-0.061	0.2053	Not reported	Not reported	Not reported

Month 1 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	75
Liso-cel Arm	88

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.08	0.400	Not reported	Not reported	Not reported
Liso-cel Arm	-0.05	0.460	Not reported	Not reported	Not reported

Month 2 potassium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.30	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 3 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	43
Liso-cel Arm	73

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.33	0.604	Not reported	Not reported	Not reported
Liso-cel Arm	0.00	0.428	Not reported	Not reported	Not reported

Month 4 potassium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.80	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

Month 6 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	31
Liso-cel Arm	66

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.11	0.337	Not reported	Not reported	Not reported
Liso-cel Arm	0.08	0.359	Not reported	Not reported	Not reported

Month 9 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	23
Liso-cel Arm	62

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.06	0.447	Not reported	Not reported	Not reported
Liso-cel Arm	0.12	0.391	Not reported	Not reported	Not reported

Month 12 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	58

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.01	0.445	Not reported	Not reported	Not reported
Liso-cel Arm	0.06	0.491	Not reported	Not reported	Not reported

Month 18 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	20
Liso-cel Arm	54

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.06	0.380	Not reported	Not reported	Not reported
Liso-cel Arm	0.15	0.411	Not reported	Not reported	Not reported

Month 24 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	16
Liso-cel Arm	48

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.09	0.516	Not reported	Not reported	Not reported
Liso-cel Arm	0.09	0.435	Not reported	Not reported	Not reported

Month 36 potassium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	40

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.07	0.549	Not reported	Not reported	Not reported
Liso-cel Arm	0.11	0.430	Not reported	Not reported	Not reported

month 1 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	75
Liso-cel Arm	88

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-2.75	3.493	Not reported	Not reported	Not reported
Liso-cel Arm	-1.09	2.875	Not reported	Not reported	Not reported

month 2 sodium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.00	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

month 3 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	44
Liso-cel Arm	73

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.86	4.496	Not reported	Not reported	Not reported
Liso-cel Arm	0.59	3.054	Not reported	Not reported	Not reported

month 4 sodium

Analysis denominator · Participants

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

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-2.00	NA	Not reported	Not reported	insufficient number of participants to calculate standard deviation

month 6 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	31
Liso-cel Arm	66

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.42	2.514	Not reported	Not reported	Not reported
Liso-cel Arm	0.33	3.222	Not reported	Not reported	Not reported

month 9 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	23
Liso-cel Arm	61

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.52	2.108	Not reported	Not reported	Not reported
Liso-cel Arm	-0.08	3.111	Not reported	Not reported	Not reported

month 12 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	58

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.33	2.114	Not reported	Not reported	Not reported
Liso-cel Arm	-0.34	4.046	Not reported	Not reported	Not reported

month 18 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	20
Liso-cel Arm	54

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	0.45	2.964	Not reported	Not reported	Not reported
Liso-cel Arm	0.74	3.572	Not reported	Not reported	Not reported

month 24 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	16
Liso-cel Arm	48

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-1.00	3.246	Not reported	Not reported	Not reported
Liso-cel Arm	1.02	3.795	Not reported	Not reported	Not reported

month 36 sodium

Analysis denominator · Participants

Group	Source count
Standard of Care Arm	18
Liso-cel Arm	40

Values in mmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	-0.44	2.229	Not reported	Not reported	Not reported
Liso-cel Arm	0.25	3.432	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.1145
value
-0.023
group Id
OG001
spread
0.0933
value
0.009
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
88
units
Participants
title
Month 1 magnesium
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-0.080
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 magnesium
categories
measurements
group Id
OG000
spread
0.1210
value
-0.063
group Id
OG001
spread
0.1010
value
0.007
denoms
counts
group Id
OG000
value
44
group Id
OG001
value
73
units
Participants
title
Month 3 magnesium
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
-0.200
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 4 magnesium
categories
measurements
group Id
OG000
spread
0.1452
value
-0.041
group Id
OG001
spread
0.1090
value
0.015
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
66
units
Participants
title
Month 6 magnesium
categories
measurements
group Id
OG000
spread
0.1459
value
-0.027
group Id
OG001
spread
0.1079
value
0.025
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
62
units
Participants
title
Month 9 magnesium
categories
measurements
group Id
OG000
spread
0.1047
value
0.012
group Id
OG001
spread
0.1054
value
0.031
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
58
units
Participants
title
Month 12 magnesium
categories
measurements
group Id
OG000
spread
0.0639
value
0.033
group Id
OG001
spread
0.1065
value
0.032
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
54
units
Participants
title
Month 18 magnesium
categories
measurements
group Id
OG000
spread
0.1145
value
0.040
group Id
OG001
spread
0.1027
value
0.015
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
48
units
Participants
title
Month 24 magnesium
categories
measurements
group Id
OG000
spread
0.0920
value
0.039
group Id
OG001
spread
0.0751
value
0.011
denoms
counts
group Id
OG000
value
18
group Id
OG001
value
41
units
Participants
title
Month 36 magnesium
categories
measurements
group Id
OG000
spread
0.2643
value
-0.061
group Id
OG001
spread
0.2498
value
-0.038
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
88
units
Participants
title
Month 1 phosphate
categories
measurements
comment
insufficient number of participants to calculate standard deviation
group Id
OG000
spread
NA
value
0.030
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
units
Participants
title
Month 2 phosphate

denoms

counts
group Id
OG000
value
76
group Id
OG001
value
88
units
Participants

description

Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. 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 Chemistry Parameters 2

type

SECONDARY

unit Of Measure

mmol/L

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

Preserved source evidence · Not medical advice