NCT03575351 · OUTCOME

Overall Survival (OS) Rate

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: Months 6, 12, 18, 24, 36

What was measured

Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause. Participants alive or lost to follow up at the time of analysis will be censored at the last date the participants was known to be alive.

Analysis population: All randomized participants

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	92
Liso-cel Arm	92

Reported measurements

OS Rate at 6 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	88.9	Not reported	82.4	95.4	Not reported
Liso-cel Arm	93.4	Not reported	88.4	98.5	Not reported

OS Rate at 12 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	72.0	Not reported	62.7	81.3	Not reported
Liso-cel Arm	83.5	Not reported	75.8	91.1	Not reported

OS Rate at 18 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	61.7	Not reported	51.5	71.8	Not reported
Liso-cel Arm	73.3	Not reported	64.2	82.5	Not reported

OS Rate at 24 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	58.2	Not reported	47.9	68.5	Not reported
Liso-cel Arm	67.5	Not reported	57.8	77.2	Not reported

OS Rate at 36 months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	51.8	Not reported	41.2	62.4	Not reported
Liso-cel Arm	62.8	Not reported	52.7	72.9	Not reported

Participants who died

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	45.7	Not reported	NA	NA	Only percentage of participants who died to be reported
Liso-cel Arm	37.0	Not reported	NA	NA	Only percentage of participants who died to be reported

Participants who were censored

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Standard of Care Arm	54.3	Not reported	NA	NA	Only percentage of participants who were censored to be reported
Liso-cel Arm	63.0	Not reported	NA	NA	Only percentage of participants who were censored to be reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
82.4
upper Limit
95.4
value
88.9
group Id
OG001
lower Limit
88.4
upper Limit
98.5
value
93.4
title
OS Rate at 6 months
categories
measurements
group Id
OG000
lower Limit
62.7
upper Limit
81.3
value
72.0
group Id
OG001
lower Limit
75.8
upper Limit
91.1
value
83.5
title
OS Rate at 12 months
categories
measurements
group Id
OG000
lower Limit
51.5
upper Limit
71.8
value
61.7
group Id
OG001
lower Limit
64.2
upper Limit
82.5
value
73.3
title
OS Rate at 18 months
categories
measurements
group Id
OG000
lower Limit
47.9
upper Limit
68.5
value
58.2
group Id
OG001
lower Limit
57.8
upper Limit
77.2
value
67.5
title
OS Rate at 24 months
categories
measurements
group Id
OG000
lower Limit
41.2
upper Limit
62.4
value
51.8
group Id
OG001
lower Limit
52.7
upper Limit
72.9
value
62.8
title
OS Rate at 36 months
categories
measurements
comment
Only percentage of participants who died to be reported
group Id
OG000
lower Limit
NA
upper Limit
NA
value
45.7
comment
Only percentage of participants who died to be reported
group Id
OG001
lower Limit
NA
upper Limit
NA
value
37.0
title
Participants who died
categories
measurements
comment
Only percentage of participants who were censored to be reported
group Id
OG000
lower Limit
NA
upper Limit
NA
value
54.3
comment
Only percentage of participants who were censored to be reported
group Id
OG001
lower Limit
NA
upper Limit
NA
value
63.0
title
Participants who were censored

denoms

counts
group Id
OG000
value
92
group Id
OG001
value
92
units
Participants

description

dispersion Type

95% Confidence Interval

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

NUMBER

population Description

All randomized participants

reporting Status

POSTED

time Frame

Months 6, 12, 18, 24, 36

title

Overall Survival (OS) Rate

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice