TriangleNCT02257567 · OUTCOME
DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC
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 the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)
What was measured
DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\> background; 2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT\>than liver \&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \& residual mass of any size at interim for LN \& ELS;residual UT\>UT in normal bone marrow but\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.
Analysis population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.
Groups in this outcome
Arm C (Phase II Randomization): Pola+BR in DLBCL
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
Arm D (Phase II Randomization): BR in DLBCL
Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
Arm F (Phase II Expansion): Pola+BG in DLBCL
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
| Group | Source count |
|---|---|
| Arm C (Phase II Randomization): Pola+BR in DLBCL | 25 |
| Arm D (Phase II Randomization): BR in DLBCL | 10 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 9 |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm C (Phase II Randomization): Pola+BR in DLBCL | 10.908 | Not reported | 5.684 | 40.674 | Not reported |
| Arm D (Phase II Randomization): BR in DLBCL | 10.645 | Not reported | 3.975 | 19.647 | Not reported |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 25.758 | Not reported | 9.692 | 46.752 | Not reported |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 13.437 | Not reported | 8.641 | 20.041 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.25
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.43
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2451
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.25
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.43
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2451
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.684
- upper Limit
- 40.674
- value
- 10.908
- group Id
- OG001
- lower Limit
- 3.975
- upper Limit
- 19.647
- value
- 10.645
- group Id
- OG002
- lower Limit
- 9.692
- upper Limit
- 46.752
- value
- 25.758
- group Id
- OG003
- lower Limit
- 8.641
- upper Limit
- 20.041
- value
- 13.437
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 61
- units
- Participants
- description
- DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\> background; 2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT\>than liver \&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \& residual mass of any size at interim for LN \& ELS;residual UT\>UT in normal bone marrow but\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
- id
- OG000
- title
- Arm C (Phase II Randomization): Pola+BR in DLBCL
- description
- Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.
- id
- OG001
- title
- Arm D (Phase II Randomization): BR in DLBCL
- description
- Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
- id
- OG002
- title
- Arm F (Phase II Expansion): Pola+BG in DLBCL
- description
- Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
- id
- OG003
- title
- Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.
- reporting Status
- POSTED
- time Frame
- From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)
- title
- DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice