NCT02601313 · OUTCOME

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18

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: Up to 5 years

Analysis population: Participants from the Safety Analysis set were analyzed.

Groups in this outcome

Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel

Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.

Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel

Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 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
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	68
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	14

Reported measurements

Grade 3 or higher decrease in hemoglobin

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	55.9	Not reported	Not reported	Not reported	Not reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	57.1	Not reported	Not reported	Not reported	Not reported

Grade 3 or higher decrease in neutrophils

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	98.5	Not reported	Not reported	Not reported	Not reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	100	Not reported	Not reported	Not reported	Not reported

Grade 3 or higher decrease in platelets

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	61.8	Not reported	Not reported	Not reported	Not reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	78.6	Not reported	Not reported	Not reported	Not reported

Grade 3 or higher decrease in leukocytes

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	98.5	Not reported	Not reported	Not reported	Not reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	92.9	Not reported	Not reported	Not reported	Not reported

Grade 3 or higher decrease in lymphocytes

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel	95.6	Not reported	Not reported	Not reported	Not reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel	100	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
55.9
group Id
OG001
value
57.1
title
Grade 3 or higher decrease in hemoglobin
categories
measurements
group Id
OG000
value
98.5
group Id
OG001
value
100
title
Grade 3 or higher decrease in neutrophils
categories
measurements
group Id
OG000
value
61.8
group Id
OG001
value
78.6
title
Grade 3 or higher decrease in platelets
categories
measurements
group Id
OG000
value
98.5
group Id
OG001
value
92.9
title
Grade 3 or higher decrease in leukocytes
categories
measurements
group Id
OG000
value
95.6
group Id
OG001
value
100
title
Grade 3 or higher decrease in lymphocytes

denoms

counts
group Id
OG000
value
68
group Id
OG001
value
14
units
Participants

groups

description
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
id
OG000
title
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
description
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
id
OG001
title
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel

param Type

NUMBER

population Description

Participants from the Safety Analysis set were analyzed.

reporting Status

POSTED

time Frame

Up to 5 years

title

Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice