NCT02601313 · OUTCOME
Change Over Time in EQ-5D Visual Analogue Scale (VAS) 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
- MEAN
- Unit
- scores on the scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Week 4, Month 3, and Month 6
What was measured
EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement.
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
| Group | Source count |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 65 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 12 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 65 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 12 |
|---|
Values in scores on the scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 82.0 | 15.4 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 82.8 | 16.1 | Not reported | Not reported | Not reported |
|---|
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 52 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 11 |
|---|
Values in scores on the scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 74.5 | 15.6 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 71.4 | 19.4 | Not reported | Not reported | Not reported |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 56 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 11 |
|---|
Values in scores on the scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 80.2 | 15.5 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 86.4 | 11.0 | Not reported | Not reported | Not reported |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 46 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 10 |
|---|
Values in scores on the scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 84.3 | 16.9 | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 89.9 | 8.0 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.4
- value
- 82.0
- group Id
- OG001
- spread
- 16.1
- value
- 82.8
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 15.6
- value
- 74.5
- group Id
- OG001
- spread
- 19.4
- value
- 71.4
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- spread
- 15.5
- value
- 80.2
- group Id
- OG001
- spread
- 11.0
- value
- 86.4
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- spread
- 16.9
- value
- 84.3
- group Id
- OG001
- spread
- 8.0
- value
- 89.9
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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
- Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score
- type
- SECONDARY
- unit Of Measure
- scores on the scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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