TriangleNCT02601313 · OUTCOME
Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
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
- 95% Confidence Interval
- Time frame
- Up to 7.8 years
What was measured
BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. Not done: no assessment at the time of analysis. Percentages were rounded off. Only categories with data are reported.
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
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 64.3 | Not reported | 35.1 | 87.2 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 21.4 | Not reported | 4.7 | 50.8 | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 7.1 | Not reported | 0.2 | 33.9 | Not reported |
Not done
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 7.1 | Not reported | 0.2 | 33.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.1
- upper Limit
- 87.2
- value
- 64.3
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 50.8
- value
- 21.4
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 33.9
- value
- 7.1
- title
- Stable disease
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 33.9
- value
- 7.1
- title
- Not done
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed. Not done: no assessment at the time of analysis. Percentages were rounded off. Only categories with data are reported.
- 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
- NUMBER
- population Description
- Participants from the mITT Analysis Set in Cohort 2 were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 7.8 years
- title
- Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice