TriangleNCT03105336 · OUTCOME
PFS Per Lugano Classification by Investigator 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
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.
Analysis population: Participants in Full Analysis Set 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) | 127 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 58.2 | Not reported | 30.9 | NA | Data for upper limit of CI was not estimable due to low number of participants with events. |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | NA | Not reported | 12.4 | NA | Data for median and upper limit of CI was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Data for upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 30.9
- upper Limit
- NA
- value
- 58.2
- comment
- Data for median and upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 12.4
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 127
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. 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 in Full Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 85.6 months
- title
- PFS Per Lugano Classification by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice