NCT02348216 · OUTCOME

Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma · Source last updated 2024-06-04

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: Not reported
Time frame: First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)

What was measured

The best overall response for each participant was based on the assessments of response (CR, PR, stable disease \[SD\], PD, and not done \[ND\]) made by the the IRRC using IWG 2007 criteria (Cheson et al, 2007). CR and PR as defined in outcome measure 2. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentage of participants with best overall response of CR, PR, SD, PD, and ND was reported.

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

Groups in this outcome

Phase 2 (Pivotal Study): Cohort 1

Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.

Phase 2 (Pivotal Study): Cohort 2

Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW 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
Phase 2 (Pivotal Study): Cohort 1	77
Phase 2 (Pivotal Study): Cohort 2	24

Reported measurements

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (Pivotal Study): Cohort 1	51	Not reported	Not reported	Not reported	Not reported
Phase 2 (Pivotal Study): Cohort 2	67	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (Pivotal Study): Cohort 1	19	Not reported	Not reported	Not reported	Not reported
Phase 2 (Pivotal Study): Cohort 2	21	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (Pivotal Study): Cohort 1	21	Not reported	Not reported	Not reported	Not reported
Phase 2 (Pivotal Study): Cohort 2	4	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (Pivotal Study): Cohort 1	8	Not reported	Not reported	Not reported	Not reported
Phase 2 (Pivotal Study): Cohort 2	4	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2 (Pivotal Study): Cohort 1	1	Not reported	Not reported	Not reported	Not reported
Phase 2 (Pivotal Study): Cohort 2	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
51
group Id
OG001
value
67
title
CR
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
21
title
PR
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
4
title
SD
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
4
title
PD
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
title
ND

denoms

counts
group Id
OG000
value
77
group Id
OG001
value
24
units
Participants

description

groups

description
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
id
OG000
title
Phase 2 (Pivotal Study): Cohort 1
description
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
id
OG001
title
Phase 2 (Pivotal Study): Cohort 2

param Type

NUMBER

population Description

Participants in the mITT Analysis Set were analyzed.

reporting Status

POSTED

time Frame

First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)

title

Phase 2 Pivotal Study (Cohorts 1 and 2): Best Overall Response Using IRRC Per Cheson 2007

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice