TriangleNCT02257567 · OUTCOME
Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC
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
- 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)
What was measured
OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).
Analysis population: ITT population included all randomized participants in Phase II 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. Values have been rounded off to the nearest whole number.
Groups in this outcome
Arm A (Phase II Randomization): Pola+BR in FL
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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 B (Phase II Randomization): BR in FL
Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 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 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 E (Phase II Expansion): Pola+BG in FL
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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 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 A (Phase II Randomization): Pola+BR in FL | 39 |
| Arm B (Phase II Randomization): BR in FL | 41 |
| Arm C (Phase II Randomization): Pola+BR in DLBCL | 40 |
| Arm D (Phase II Randomization): BR in DLBCL | 40 |
| Arm E (Phase II Expansion): Pola+BG in FL | 20 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 21 |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Phase II Randomization): Pola+BR in FL | 74.4 | Not reported | 57.87 | 86.96 | Not reported |
| Arm B (Phase II Randomization): BR in FL | 80.5 | Not reported | 65.13 | 91.18 | Not reported |
| Arm C (Phase II Randomization): Pola+BR in DLBCL | 40.0 | Not reported | 24.86 | 56.67 | Not reported |
| Arm D (Phase II Randomization): BR in DLBCL | 15.0 | Not reported | 5.71 | 29.84 | Not reported |
| Arm E (Phase II Expansion): Pola+BG in FL | 80.0 | Not reported | 56.34 | 94.27 | Not reported |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 38.1 | Not reported | 18.11 | 61.56 | Not reported |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 41.5 | Not reported | 32.02 | 51.49 | Not reported |
Source statistical analyses
- ci Lower Limit
- -24.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.12
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4835
- param Type
- Difference in Response Rates
- param Value
- -6.13
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 5.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.33
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0096
- param Type
- Difference in Response Rates
- param Value
- 25.00
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -24.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.12
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.4835
- param Type
- Difference in Response Rates
- param Value
- -6.13
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 5.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 42.33
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0096
- param Type
- Difference in Response Rates
- param Value
- 25.00
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57.87
- upper Limit
- 86.96
- value
- 74.4
- group Id
- OG001
- lower Limit
- 65.13
- upper Limit
- 91.18
- value
- 80.5
- group Id
- OG002
- lower Limit
- 24.86
- upper Limit
- 56.67
- value
- 40.0
- group Id
- OG003
- lower Limit
- 5.71
- upper Limit
- 29.84
- value
- 15.0
- group Id
- OG004
- lower Limit
- 56.34
- upper Limit
- 94.27
- value
- 80.0
- group Id
- OG005
- lower Limit
- 18.11
- upper Limit
- 61.56
- value
- 38.1
- group Id
- OG006
- lower Limit
- 32.02
- upper Limit
- 51.49
- value
- 41.5
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 40
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 106
- units
- Participants
- description
- OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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 A (Phase II Randomization): Pola+BR in FL
- description
- Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 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 B (Phase II Randomization): BR in FL
- 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
- OG002
- 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
- OG003
- title
- Arm D (Phase II Randomization): BR in DLBCL
- description
- Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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
- OG004
- title
- Arm E (Phase II Expansion): Pola+BG in FL
- 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
- OG005
- 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
- OG006
- title
- Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants in Phase II 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. Values have been rounded off to the nearest whole number.
- reporting Status
- POSTED
- time Frame
- 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)
- title
- Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice