Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02601313 · OUTCOME

Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry 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

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel68
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel14

Reported measurements

Grade 3 or higher increase in Potassium
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Calcium
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Magnesium
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel2.9Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel7.1Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Sodium
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel4.4Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Alanine aminotransferase
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel14.7Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel14.3Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Aspartate aminotransferase
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel14.7Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel14.3Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Bilirubin
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel1.5Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Creatinine
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel5.9Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel7.1Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Urate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel16.2Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel21.4Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Direct bilirubin
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel2.9Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel14.3Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Glucose
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel5.9Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel21.4Not reportedNot reportedNot reportedNot reported
Grade 3 or higher increase in Alkaline phosphatase
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in Potassium
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in Calcium
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2.9
      2. group Id
        OG001
        value
        7.1
    title
    Grade 3 or higher increase in Magnesium
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.4
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in Sodium
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        14.7
      2. group Id
        OG001
        value
        14.3
    title
    Grade 3 or higher increase in Alanine aminotransferase
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14.7
      2. group Id
        OG001
        value
        14.3
    title
    Grade 3 or higher increase in Aspartate aminotransferase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in Bilirubin
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
      2. group Id
        OG001
        value
        7.1
    title
    Grade 3 or higher increase in Creatinine
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        16.2
      2. group Id
        OG001
        value
        21.4
    title
    Grade 3 or higher increase in Urate
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2.9
      2. group Id
        OG001
        value
        14.3
    title
    Grade 3 or higher increase in Direct bilirubin
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
      2. group Id
        OG001
        value
        21.4
    title
    Grade 3 or higher increase in Glucose
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in Alkaline phosphatase
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      14
    units
    Participants
groups
  1. 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
  2. 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 Increase in Post-brexucabtagene Autoleucel Infusion Chemistry 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