NCT02601313 · OUTCOME
Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) · Source last updated 2026-03-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 5 years
Analysis population: Participants from the Safety Analysis Set were analyzed.
Groups in this outcome
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 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 |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 68 |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 14 |
|---|
Reported measurements
Grade 3 or higher decrease in Potassium
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 10.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 7.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Calcium
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 17.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 35.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Magnesium
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Sodium
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 13.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 28.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Albumin
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 7.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 7.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Glucose
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 1.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 7.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3 or higher decrease in Phosphate
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 30.9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 28.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10.3
- group Id
- OG001
- value
- 7.1
- title
- Grade 3 or higher decrease in Potassium
- categories
- measurements
- group Id
- OG000
- value
- 17.6
- group Id
- OG001
- value
- 35.7
- title
- Grade 3 or higher decrease in Calcium
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 3 or higher decrease in Magnesium
- categories
- measurements
- group Id
- OG000
- value
- 13.2
- group Id
- OG001
- value
- 28.6
- title
- Grade 3 or higher decrease in Sodium
- categories
- measurements
- group Id
- OG000
- value
- 7.4
- group Id
- OG001
- value
- 7.1
- title
- Grade 3 or higher decrease in Albumin
- categories
- measurements
- group Id
- OG000
- value
- 1.5
- group Id
- OG001
- value
- 7.1
- title
- Grade 3 or higher decrease in Glucose
- categories
- measurements
- group Id
- OG000
- value
- 30.9
- group Id
- OG001
- value
- 28.6
- title
- Grade 3 or higher decrease in Phosphate
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 14
- units
- Participants
- groups
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG000
- title
- Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG001
- title
- Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
- param Type
- NUMBER
- population Description
- Participants from the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle