NCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Source last updated 2026-03-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Screening, Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12
What was measured
The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".
Analysis population: Participants in substudies B, C and D, in the Safety Analysis Set with available data were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
Groups in this outcome
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
This substudy was withdrawn; therefore, no participants were enrolled.
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study:
Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/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 |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Reported measurements
Screening
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 58.8 | 31.2 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 65.0 | 18.6 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 65.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Lymphodepleting Chemotherapy Day -5
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 9 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3.8 | 21.4 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | -8.3 | 15.0 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 10.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Day 0
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1.3 | 8.5 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | -0.5 | 8.3 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | -5.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Day 28
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 2 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 9 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | -10.0 | 0.0 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | -0.6 | 15.3 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 10.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 2 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 7 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 2.5 | 17.7 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 6.4 | 26.1 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 15.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 2 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 4 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | -5.0 | 21.2 | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | -3.8 | 13.1 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 20.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Month 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 1 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | -20.1 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 50.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 15.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel | 0 |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 3 |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 |
|---|
Values in score on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | -10.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 20.0 | 40.9 | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 5.0 | NA | Not reported | Not reported | Standard Deviation cannot be estimated for one participant. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 31.2
- value
- 58.8
- group Id
- OG002
- spread
- 18.6
- value
- 65.0
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 65.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Screening
- categories
- measurements
- group Id
- OG001
- spread
- 21.4
- value
- 3.8
- group Id
- OG002
- spread
- 15.0
- value
- -8.3
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Lymphodepleting Chemotherapy Day -5
- categories
- measurements
- group Id
- OG001
- spread
- 8.5
- value
- 1.3
- group Id
- OG002
- spread
- 8.3
- value
- -0.5
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- -5.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Day 0
- categories
- measurements
- group Id
- OG001
- spread
- 0.0
- value
- -10.0
- group Id
- OG002
- spread
- 15.3
- value
- -0.6
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Day 28
- categories
- measurements
- group Id
- OG001
- spread
- 17.7
- value
- 2.5
- group Id
- OG002
- spread
- 26.1
- value
- 6.4
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 15.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Month 3
- categories
- measurements
- group Id
- OG001
- spread
- 21.2
- value
- -5.0
- group Id
- OG002
- spread
- 13.1
- value
- -3.8
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 20.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Month 6
- categories
- measurements
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG001
- spread
- NA
- value
- -20.1
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG002
- spread
- NA
- value
- 50.0
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 15.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Month 9
- categories
- measurements
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG001
- spread
- NA
- value
- -10.0
- group Id
- OG002
- spread
- 40.9
- value
- 20.0
- comment
- Standard Deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 5.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- Month 12
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- The EQ-VAS recorded the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".
- dispersion Type
- Standard Deviation
- groups
- description
- This substudy was withdrawn; therefore, no participants were enrolled.
- id
- OG000
- title
- Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
- description
- Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study:
Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
- id
- OG001
- title
- Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
- description
- Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
- id
- OG002
- title
- Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
- description
- Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
- id
- OG003
- title
- Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
- param Type
- MEAN
- population Description
- Participants in substudies B, C and D, in the Safety Analysis Set with available data were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
- reporting Status
- POSTED
- time Frame
- Screening, Day -5, Day 0, Day 28, Month 3, Month 6, Month 9 and Month 12
- title
- All Substudies (Substudies A, B, C and D): Change From Screening in the EQ-ED-5L Visual Analogue Scale (EQ-VAS) Score
- type
- SECONDARY
- unit Of Measure
- score on scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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