TriangleNCT03391466 · OUTCOME
Objective Response Rate (ORR) Per Blinded Central Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization date up to a median follow-up: 24.9 months
What was measured
ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \>liver), 5 (uptake markedly \>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \>50% if previously enlarged, no new lesion sites.
Analysis population: Participants in the Full Analysis Set were analyzed.
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 | 180 |
| Standard of Care Therapy | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Axicabtagene Ciloleucel | 83 | Not reported | 77.1 | 88.5 | Not reported |
| Standard of Care Therapy | 50 | Not reported | 42.7 | 57.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 23.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.1
- estimate Comment
- 95% CI for the difference in ORR was from Wilson's score method with continuity correction.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- One-sided p-value based on Cochran-Mantel-Haenszel (CMH) test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified (randomization factor) CMH test p-value.
- param Type
- Difference in ORR
- param Value
- 33.1
- statistical Comment
- Stratified (randomization factor) CMH test.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 23.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.1
- estimate Comment
- 95% CI for the difference in ORR was from Wilson's score method with continuity correction.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- One-sided p-value based on Cochran-Mantel-Haenszel (CMH) test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- Stratified (randomization factor) CMH test p-value.
- param Type
- Difference in ORR
- param Value
- 33.1
- statistical Comment
- Stratified (randomization factor) CMH test.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.1
- upper Limit
- 88.5
- value
- 83
- group Id
- OG001
- lower Limit
- 42.7
- upper Limit
- 57.8
- value
- 50
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \>liver), 5 (uptake markedly \>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \>50% if previously enlarged, no new lesion sites.
- 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
- NUMBER
- population Description
- Participants in the Full Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- From randomization date up to a median follow-up: 24.9 months
- title
- Objective Response Rate (ORR) Per Blinded Central Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice