TriangleNCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- First infusion date of brexucabtagene autoleucel up to 28 days
What was measured
Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion.
Analysis population: Participants in Substudies B, C, and D in DLT Evaluable Set were analyzed. DLT Evaluable Set consisted of first 3 participants treated. When 1 of these participants experienced a DLT within 28 days post-brexucabtagene autoleucel infusion, 3 more participants were added. This resulted in more than 3 DLT evaluable participants in Substudies B \& C, and only 1 extra participant enrolled in Substudy B due to early study termination. Substudy A was withdrawn before enrollment, so no data is available.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This substudy was withdrawn; therefore, no participants were enrolled.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 | 6 |
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- units
- Participants
- description
- Dose-limiting toxicity is defined as protocol-defined brexucabtagene autoleucel-related events with onset within the first 28 days following brexucabtagene autoleucel infusion.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Participants in Substudies B, C, and D in DLT Evaluable Set were analyzed. DLT Evaluable Set consisted of first 3 participants treated. When 1 of these participants experienced a DLT within 28 days post-brexucabtagene autoleucel infusion, 3 more participants were added. This resulted in more than 3 DLT evaluable participants in Substudies B \& C, and only 1 extra participant enrolled in Substudy B due to early study termination. Substudy A was withdrawn before enrollment, so no data is available.
- reporting Status
- POSTED
- time Frame
- First infusion date of brexucabtagene autoleucel up to 28 days
- title
- All Substudies (Substudies A, B, C and D): Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice