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NCT02601313 · OUTCOME

Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score

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
Baseline, Week 4, Month 3, and Month 6

What was measured

The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported. Percentages were rounded off.

Analysis population: Participants from the Safety Analysis Set with available data 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 Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12

Reported measurements

Baseline: Not anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel75Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel67Not reportedNot reportedNot reportedNot reported
Baseline: Slight anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel20Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel33Not reportedNot reportedNot reportedNot reported
Baseline: Moderate anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel5Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Baseline: Severe anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12
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
Baseline: Extreme anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel65
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel12
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
Week 4: Not anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel54
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel67Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel73Not reportedNot reportedNot reportedNot reported
Week 4: Slight anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel54
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel26Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel27Not reportedNot reportedNot reportedNot reported
Week 4: Moderate anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel54
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel6Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Week 4: Severe anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel54
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel2Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Week 4: Extreme anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel54
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
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
Month 3: Not anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel56
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel70Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel91Not reportedNot reportedNot reportedNot reported
Month 3: Slight anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel56
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel21Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel9Not reportedNot reportedNot reportedNot reported
Month 3: Moderate anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel56
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel9Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Month 3: Severe anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel56
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
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
Month 3: Extreme anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel56
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel11
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
Month 6: Not anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel46
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel63Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel90Not reportedNot reportedNot reportedNot reported
Month 6: Slight anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel46
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel26Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10Not reportedNot reportedNot reportedNot reported
Month 6: Moderate anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel46
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel11Not reportedNot reportedNot reportedNot reported
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Month 6: Severe anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel46
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10
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
Month 6: Extreme anxious or depressed

Analysis denominator · Participants

GroupSource count
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel46
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel10
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
        75
      2. group Id
        OG001
        value
        67
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline: Not anxious or depressed
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        33
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline: Slight anxious or depressed
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline: Moderate anxious or depressed
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline: Severe anxious or depressed
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Baseline: Extreme anxious or depressed
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        73
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 4: Not anxious or depressed
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        27
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 4: Slight anxious or depressed
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 4: Moderate anxious or depressed
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 4: Severe anxious or depressed
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 4: Extreme anxious or depressed
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        91
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Month 3: Not anxious or depressed
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        9
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Month 3: Slight anxious or depressed
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      12
    units
    Participants
description
The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported. Percentages were rounded off.
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 with available data were analyzed.
reporting Status
POSTED
time Frame
Baseline, Week 4, Month 3, and Month 6
title
Percentage of Participants With Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice