TriangleNCT03105336 · OUTCOME
Duration of Response (DOR) by Central Assessment
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 85.6 months
What was measured
DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis.
Analysis population: Participants with OR in the Full Analysis Set with available data were analyzed
Groups in this outcome
Axicabtagene Ciloleucel (Follicular Lymphoma)
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
| Group | Source count |
|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 117 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 38.6 | Not reported | NA | NA | Lower and upper limit of confidence intervals (CI) could not be estimated due to limited number of events and censoring. The Median was estimated because the longest observed participant event crossed 50%. |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | NA | Not reported | 8.2 | NA | Data for median and upper limit of CI were not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Lower and upper limit of confidence intervals (CI) could not be estimated due to limited number of events and censoring. The Median was estimated because the longest observed participant event crossed 50%.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 38.6
- comment
- Data for median and upper limit of CI were not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 8.2
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG000
- title
- Axicabtagene Ciloleucel (Follicular Lymphoma)
- description
- Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG001
- title
- Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
- param Type
- MEDIAN
- population Description
- Participants with OR in the Full Analysis Set with available data were analyzed
- reporting Status
- POSTED
- time Frame
- Up to 85.6 months
- title
- Duration of Response (DOR) by Central Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice