NCT03105336 · OUTCOME

Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

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: Up to 85.6 months

What was measured

BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off.

Analysis population: Participants in the Full Analysis Set were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel (Follicular Lymphoma)

Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

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
Axicabtagene Ciloleucel (Follicular Lymphoma)	127
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	31

Reported measurements

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	79	Not reported	71	85	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	65	Not reported	45	81	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	15	Not reported	9	22	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	13	Not reported	4	30	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2	Not reported	0	6	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	10	Not reported	2	26	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	2	Not reported	0	6	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	3	Not reported	0	17	Not reported

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	0	Not reported	0	3	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	0	Not reported	0	11	Not reported

Not Done

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)	3	Not reported	1	8	Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)	10	Not reported	2	26	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
71
upper Limit
85
value
79
group Id
OG001
lower Limit
45
upper Limit
81
value
65
title
CR
categories
measurements
group Id
OG000
lower Limit
9
upper Limit
22
value
15
group Id
OG001
lower Limit
4
upper Limit
30
value
13
title
PR
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
6
value
2
group Id
OG001
lower Limit
2
upper Limit
26
value
10
title
SD
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
6
value
2
group Id
OG001
lower Limit
0
upper Limit
17
value
3
title
PD
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
3
value
0
group Id
OG001
lower Limit
0
upper Limit
11
value
0
title
NE
categories
measurements
group Id
OG000
lower Limit
1
upper Limit
8
value
3
group Id
OG001
lower Limit
2
upper Limit
26
value
10
title
Not Done

denoms

counts
group Id
OG000
value
127
group Id
OG001
value
31
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG000
title
Axicabtagene Ciloleucel (Follicular Lymphoma)
description
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
id
OG001
title
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

param Type

NUMBER

population Description

Participants in the Full Analysis Set were analyzed.

reporting Status

POSTED

time Frame

Up to 85.6 months

title

Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice