NCT05537766 · OUTCOME
All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- First dose date up to 2 years
What was measured
Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
Analysis population: Participants in substudies B, C and D, in the Safety 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 Substudy A was withdrawn, therefore no participants were enrolled in it.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This substudy was withdrawn; therefore, no participants were enrolled.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 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
Hemoglobin (mmol/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes (10^9/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (10^9/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 | 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 |
|---|
Neutrophils (10^9/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelets (10^9/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Glucose (mmol/L)
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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 |
|---|
Calcium (mmol/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 1 | 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 |
|---|
Potassium (mmol/L)
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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 |
|---|
Sodium (mmol/L)
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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 |
|---|
Phosphate (mmol/L)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel | 4 | 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 |
|---|
Magnesium (mmol/L)
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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 |
|---|
Albumin (g/L)
Values in Participants · Interval/dispersion: Not reported| 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 | 0 | 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
- 1
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- title
- Hemoglobin (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- title
- Leukocytes (10^9/L)
- categories
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Lymphocytes (10^9/L)
- categories
- measurements
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 1
- title
- Neutrophils (10^9/L)
- categories
- measurements
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 1
- title
- Platelets (10^9/L)
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Glucose (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Calcium (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Potassium (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Sodium (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- title
- Phosphate (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Magnesium (mmol/L)
- categories
- measurements
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Albumin (g/L)
- 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
- Laboratory results were graded according to NCI CTCAE version 5.0. The incidence of post-infusion worst-grade lab toxicities for all analytes were summarized.
- 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 the Safety 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
- First dose date up to 2 years
- title
- All Substudies (Substudies A, B, C and D): Number of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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