TriangleNCT02348216 · OUTCOME
Phase 2 Pivotal Study (Cohorts 1 and 2): PFS Using IRRC Per Cheson 2007
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
- First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)
What was measured
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. KM estimates was used for analyses.
Analysis population: Participants in the mITT Analysis Set were analyzed.
Groups in this outcome
Phase 2 (Pivotal Study): Cohort 1
Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
Phase 2 (Pivotal Study): Cohort 2
Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
| Group | Source count |
|---|---|
| Phase 2 (Pivotal Study): Cohort 1 | 77 |
| Phase 2 (Pivotal Study): Cohort 2 | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (Pivotal Study): Cohort 1 | 6.9 | Not reported | 4.5 | 15.0 | Not reported |
| Phase 2 (Pivotal Study): Cohort 2 | NA | Not reported | 9.0 | NA | Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 15.0
- value
- 6.9
- comment
- Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
- group Id
- OG001
- lower Limit
- 9.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression as assessed by the IRRC using revised IWG Response Criteria for Malignant Lymphoma (Cheson et al, 2007) or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. PD defined by at least one of the following: ≥ 50% increase from nadir in the sum of the products of at least 2 lymph nodes, or at least a 50% increase in the product of the diameters of a single lymph node; appearance of a new lesion \> 1.5 cm in any axis; ≥ 50% increase in size of splenic or hepatic nodules; ≥ 50% increase in the longest diameter of any single previously identified node \> 1 cm in its short axis. KM estimates was used for analyses.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
- id
- OG000
- title
- Phase 2 (Pivotal Study): Cohort 1
- description
- Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0.
- id
- OG001
- title
- Phase 2 (Pivotal Study): Cohort 2
- param Type
- MEDIAN
- population Description
- Participants in the mITT Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- First infusion date of axicabtagene ciloleucel to the data cutoff date of 11 August 2018 (maximum: 2.7 years)
- title
- Phase 2 Pivotal Study (Cohorts 1 and 2): PFS Using IRRC Per Cheson 2007
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice