TriangleNCT02601313 · OUTCOME
Duration of Response (DOR) in Cohort 2 as Per Investigator Response
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
DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately \> liver)/5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi \> 1.5 cm, increase by ≥ 50% from cross-product of LDi and PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
Analysis population: Participants from the mITT analysis Set with objective response in Cohort 2 were analyzed. Participants not meeting the criteria for DOR at the time of data analysis were censored at their last evaluable disease assessment date.
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 | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 57.5 | Not reported | 4.7 | NA | Data for upper limit of CI is not available due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data for upper limit of CI is not available due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- NA
- value
- 57.5
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately \> liver)/5 (uptake markedly \>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi \> 1.5 cm, increase by ≥ 50% from cross-product of LDi and PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by \> 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
- 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 with objective response in Cohort 2 were analyzed. Participants not meeting the criteria for DOR at the time of data analysis were censored at their last evaluable disease assessment date.
- reporting Status
- POSTED
- time Frame
- Up to 7.8 years
- title
- Duration of Response (DOR) in Cohort 2 as Per Investigator Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice