TriangleNCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Time to First Objective Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- days
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 2 years
What was measured
Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).
Analysis population: Participants in substudies B, C and D, in the Modified Intent-to-Treat Analysis Set with objective response 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 Substudy A was withdrawn, therefore no participants were enrolled in it.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This substudy was withdrawn; therefore, no participants were enrolled.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 | 2 |
| 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 | 38.0 | 7.07 | Not reported | Not reported | Not reported |
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 55.3 | 80.48 | Not reported | Not reported | Not reported |
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 27.0 | NA | Not reported | Not reported | Standard deviation cannot be estimated for one participant. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 7.07
- value
- 38.0
- group Id
- OG002
- spread
- 80.48
- value
- 55.3
- comment
- Standard deviation cannot be estimated for one participant.
- group Id
- OG003
- spread
- NA
- value
- 27.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Time to first objective response was defined as time from the date of brexucabtagene autoleucel infusion to the date of first response per the Sixth International Workshop in WM for r/rWM, per the Lugano Classification for r/rRT and r/r BL, and per Grever and colleagues for r/rHCL. Objective response (OR) is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D).
- 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 Modified Intent-to-Treat Analysis Set with objective response 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): Time to First Objective Response
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice