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NCT02601313 · OUTCOME

Percentage of Participants With Increase 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 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 leukocytes
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 lymphocytes
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in leukocytes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or higher increase in lymphocytes
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 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 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