Analysis population: Participants in the Safety Analysis Set with available data 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)
124
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Reported measurements
Serum Ferritin on Baseline
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
330.54
398.03
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
207.63
218.42
Not reported
Not reported
Not reported
Serum Ferritin on Day 0
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
503.99
502.07
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
398.49
337.82
Not reported
Not reported
Not reported
Serum Ferritin on Day 3
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
27
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
541.51
457.18
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
487.39
414.90
Not reported
Not reported
Not reported
Serum Ferritin on Day 7
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
779.75
782.98
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
1820.38
4837.56
Not reported
Not reported
Not reported
Serum Ferritin on Week 2
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
26
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
741.76
787.70
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
959.49
1546.07
Not reported
Not reported
Not reported
Serum Ferritin on Week 4
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
528.83
605.94
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
478.47
459.54
Not reported
Not reported
Not reported
Serum ICAM-1 on Baseline
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
876.99
833.80
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
709.71
430.14
Not reported
Not reported
Not reported
Serum ICAM-1 on Day 0
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
834.87
854.35
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
642.60
365.92
Not reported
Not reported
Not reported
Serum ICAM-1 on Day 3
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
27
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
964.45
904.79
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
792.47
621.84
Not reported
Not reported
Not reported
Serum ICAM-1 on Day 7
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
924.99
846.56
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
934.02
618.96
Not reported
Not reported
Not reported
Serum ICAM-1 on Week 2
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
26
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
695.15
605.03
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
696.77
438.71
Not reported
Not reported
Not reported
Serum ICAM-1 on Week 4
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
671.32
656.46
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
614.92
487.67
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Baseline
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
8.52
12.15
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
5.62
7.50
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Day 0
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
8.39
9.10
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
4.91
4.12
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Day 3
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
27
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
9.96
11.53
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
7.31
5.68
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Day 7
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
14.42
15.10
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
19.78
20.82
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Week 2
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
26
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
7.16
8.27
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
10.40
12.26
Not reported
Not reported
Not reported
Serum IL-2 R alpha on Week 4
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
3.39
3.34
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
4.02
3.67
Not reported
Not reported
Not reported
Serum Perforin on Baseline
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
13.26
7.20
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
13.58
18.33
Not reported
Not reported
Not reported
Serum Perforin on Day 0
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
2.56
1.85
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
3.30
9.11
Not reported
Not reported
Not reported
Serum Perforin on Day 3
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
27
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
3.87
3.36
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
4.71
13.53
Not reported
Not reported
Not reported
Serum Perforin on Day 7
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
124
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
8.49
10.54
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
6.60
7.99
Not reported
Not reported
Not reported
Serum Perforin on Week 2
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
26
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
8.06
6.90
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
6.01
6.77
Not reported
Not reported
Not reported
Serum Perforin on Week 4
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
14.56
11.92
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
12.32
12.08
Not reported
Not reported
Not reported
Serum VCAM-1 on Baseline
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
122
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
1499.37
1637.98
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
1282.81
1232.76
Not reported
Not reported
Not reported
Serum VCAM-1 on Day 0
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
121
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
1182.41
1166.58
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
931.58
709.94
Not reported
Not reported
Not reported
Serum VCAM-1 on Day 3
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
106
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
27
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
1213.84
962.38
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
1044.96
870.11
Not reported
Not reported
Not reported
Serum VCAM-1 on Day 7
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
123
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
1224.58
1069.13
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
1209.51
780.31
Not reported
Not reported
Not reported
Serum VCAM-1 on Week 2
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
113
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
26
Values in ng/L · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Axicabtagene Ciloleucel (Follicular Lymphoma)
891.64
726.10
Not reported
Not reported
Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
977.88
919.47
Not reported
Not reported
Not reported
Serum VCAM-1 on Week 4
Analysis denominator · Participants
Group
Source count
Axicabtagene Ciloleucel (Follicular Lymphoma)
118
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
28
Values in ng/L · Interval/dispersion: Standard Deviation
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
MEAN
population Description
Participants in the Safety Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
title
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1