NCT02601313 · OUTCOME
Maximum Number of CAR T Cells Measured Post-infusion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- cells/μL
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Month 24
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 | Source count |
|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 68 |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 313.02 | 586.17 | Not reported | Not reported | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 96.69 | 109.33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 586.17
- value
- 313.02
- group Id
- OG001
- spread
- 109.33
- value
- 96.69
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 14
- units
- Participants
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Participants from the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to Month 24
- title
- Maximum Number of CAR T Cells Measured Post-infusion
- type
- SECONDARY
- unit Of Measure
- cells/μL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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