TriangleNCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Duration of Response (DOR)
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
DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: score 4 (uptake moderately \>liver) or 5 (uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow.
Analysis population: The Modified Intent-to-Treat Analysis Set consisted of all participants enrolled and treated with pivotal dose of brexucabtagene autoleucel, with measurable disease at baseline (or post-bridging therapy, if applicable). 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 Substudy A was withdrawn, therefore no participants were enrolled in it.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This substudy was withdrawn; therefore, no participants were enrolled.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 | NA | Not reported | 4.6 | NA | Median and upper limit of CI were not estimable due to low number of participants with events. |
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 5.0 | Not reported | 2.2 | 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 | 11.3 | 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
- Median and upper limit of CI were not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG002
- lower Limit
- 2.2
- upper Limit
- NA
- value
- 5.0
- 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
- 11.3
- 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
- DOR was defined as time from first objective response (OR) to disease progression (PD) or death. OR is defined in OM#25 (Substudy B), 28 (Substudy C), and 29 (Substudy D). PD: score 4 (uptake moderately \>liver) or 5 (uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow.
- 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
- The Modified Intent-to-Treat Analysis Set consisted of all participants enrolled and treated with pivotal dose of brexucabtagene autoleucel, with measurable disease at baseline (or post-bridging therapy, if applicable). 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): Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice