TriangleNCT02348216 · OUTCOME
Phase 2: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
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 disease progression or death regardless of cause (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Cohorts 1, 2, 3, 4, 5, and 6 respectively)
What was measured
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the 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. Disease progression was 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.
Phase 2 (Safety Management Study): Cohort 3
Participants with relapsed or refractory transplant ineligible DLBCL, 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. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
Phase 2 (Safety Management Study): Cohort 4
Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
Phase 2 (Safety Management Study): Cohort 5
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
Phase 2 (Safety Management Study): Cohort 6
Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
| Group | Source count |
|---|---|
| Phase 2 (Pivotal Study): Cohort 1 | 77 |
| Phase 2 (Pivotal Study): Cohort 2 | 24 |
| Phase 2 (Safety Management Study): Cohort 3 | 38 |
| Phase 2 (Safety Management Study): Cohort 4 | 41 |
| Phase 2 (Safety Management Study): Cohort 5 | 50 |
| Phase 2 (Safety Management Study): Cohort 6 | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 (Pivotal Study): Cohort 1 | 5.1 | Not reported | 3.0 | 8.8 | Not reported |
| Phase 2 (Pivotal Study): Cohort 2 | 49.1 | Not reported | 3.7 | NA | Upper limit of 95% CI was not estimable because almost 50% of participants were censored. |
| Phase 2 (Safety Management Study): Cohort 3 | 6.2 | Not reported | 2.4 | NA | Upper limit of 95% CI was not estimable because almost 50% of participants were censored. |
| Phase 2 (Safety Management Study): Cohort 4 | NA | Not reported | 3.0 | NA | Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored. |
| Phase 2 (Safety Management Study): Cohort 5 | 3.1 | Not reported | 2.9 | 29.1 | Not reported |
| Phase 2 (Safety Management Study): Cohort 6 | NA | Not reported | 8.7 | 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
- 3.0
- upper Limit
- 8.8
- value
- 5.1
- comment
- Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- NA
- value
- 49.1
- comment
- Upper limit of 95% CI was not estimable because almost 50% of participants were censored.
- group Id
- OG002
- lower Limit
- 2.4
- upper Limit
- NA
- value
- 6.2
- comment
- Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
- group Id
- OG003
- lower Limit
- 3.0
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 2.9
- upper Limit
- 29.1
- value
- 3.1
- comment
- Median and upper limit of 95% CI was not estimable because almost 50% of participants were censored.
- group Id
- OG005
- lower Limit
- 8.7
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 41
- group Id
- OG004
- value
- 50
- group Id
- OG005
- value
- 40
- units
- Participants
- description
- PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the 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. Disease progression was 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
- description
- Participants with relapsed or refractory transplant ineligible DLBCL, 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. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).
- id
- OG002
- title
- Phase 2 (Safety Management Study): Cohort 3
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
- id
- OG003
- title
- Phase 2 (Safety Management Study): Cohort 4
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\^2 D1,doxorubicin 50mg/m\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\^2 D1,vincristine 1.4 mg/m\^2 D1 or R-ICE:rituximab 375mg/ m\^2 D1,ifosfamide 5g/m\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\^2 D1,gemcitabine 1000mg/m\^2 D2,oxaliplatin 100mg/m\^2 D2 or R-GDP:rituximab 375mg/m\^2 D1 or D8,gemcitabine 1g/m\^2 D1 \& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.
- id
- OG004
- title
- Phase 2 (Safety Management Study): Cohort 5
- description
- Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\^2 weekly for 3 weeks or bendamustine 90 mg/m\^2 on Days 1 and 2 and rituximab 375mg/m\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\^2 IV and cyclophosphamide 500mg/m\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).
- id
- OG005
- title
- Phase 2 (Safety Management Study): Cohort 6
- 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 disease progression or death regardless of cause (maximum duration: 7.7, 6.8, 5.4, 4.4, 4.1 years for Cohorts 1, 2, 3, 4, 5, and 6 respectively)
- title
- Phase 2: Progression-Free Survival (PFS) as Assessed by Investigator Per Revised IWG Response Criteria for Malignant Lymphoma
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice