TriangleNCT02601313 · OUTCOME
Overall Survival in Cohort 2
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 7.8 years
What was measured
Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
Analysis population: Participants from the mITT Analysis Set in Cohort 2 were analyzed.
Groups in this outcome
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 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | NA | Not reported | 9.4 | NA | Median and upper limit of CI were not reached due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of CI were not reached due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
- dispersion Type
- 95% Confidence Interval
- 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 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
- OG000
- title
- Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
- param Type
- MEDIAN
- population Description
- Participants from the mITT Analysis Set in Cohort 2 were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 7.8 years
- title
- Overall Survival in Cohort 2
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice