TriangleNCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 years
What was measured
PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6.
Analysis population: Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set 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 Substudy A was withdrawn, therefore no participants were enrolled in it.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This substudy was withdrawn; therefore, no participants were enrolled.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 | 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3.5 | Not reported | 0.7 | NA | Upper limit of CI was not estimable due to low number of participants with events. |
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 5.8 | Not reported | 3.1 | NA | Upper limit of CI was not estimable due to low number of participants with events. |
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 12.1 | Not reported | NA | NA | Lower and upper limit of 95% CI could not be calculated for 1 participant. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- NA
- value
- 3.5
- comment
- Upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG002
- lower Limit
- 3.1
- upper Limit
- NA
- value
- 5.8
- comment
- Lower and upper limit of 95% CI could not be calculated for 1 participant.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 12.1
- 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
- PFS was defined as the time from the date of brexucabtagene autoleucel infusion to the date of PD or death from any cause. PD is defined in outcome measure #6.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- All Substudies (Substudies A, B, C and D): Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice