TriangleNCT03391466 · OUTCOME
Duration of Response (DOR) Per Blinded Central Assessments
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
- From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)
What was measured
DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.
Analysis population: Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier.
Groups in this outcome
Axicabtagene Ciloleucel
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Standard of Care Therapy
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
| Group | Source count |
|---|---|
| Axicabtagene Ciloleucel | 150 |
| Standard of Care Therapy | 90 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel | 26.9 | Not reported | 13.6 | NA | Upper limit of CI was not reached due to insufficient number of events. |
| Standard of Care Therapy | 8.9 | Not reported | 5.7 | NA | Upper limit of CI was not reached due to insufficient number of events. |
Source statistical analyses
- ci Lower Limit
- 0.488
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.108
- estimate Comment
- Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0695
- p Value Comment
- Stratified (randomization stratification factors) log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.736
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.488
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.108
- estimate Comment
- Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0695
- p Value Comment
- Stratified (randomization stratification factors) log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.736
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of CI was not reached due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 13.6
- upper Limit
- NA
- value
- 26.9
- comment
- Upper limit of CI was not reached due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- NA
- value
- 8.9
- denoms
- counts
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 90
- units
- Participants
- description
- DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG000
- title
- Axicabtagene Ciloleucel
- description
- Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
- id
- OG001
- title
- Standard of Care Therapy
- param Type
- MEDIAN
- population Description
- Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier.
- reporting Status
- POSTED
- time Frame
- From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)
- title
- Duration of Response (DOR) Per Blinded Central Assessments
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice