TriangleNCT02257567 · OUTCOME
Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator
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
- Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)
What was measured
BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver \&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \& ELS, score=4 or 5, reduced UT than baseline (BL) \& residual mass of any size;residual UT\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.
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 | 89.7 | Not reported | 75.78 | 97.13 | Not reported |
| Arm B (Phase II Randomization): BR in FL | 90.2 | Not reported | 76.87 | 97.28 | Not reported |
| Arm C (Phase II Randomization): Pola+BR in DLBCL | 70.0 | Not reported | 53.47 | 83.44 | Not reported |
| Arm D (Phase II Randomization): BR in DLBCL | 32.5 | Not reported | 18.57 | 49.13 | Not reported |
| Arm E (Phase II Expansion): Pola+BG in FL | 90.0 | Not reported | 68.30 | 98.77 | Not reported |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 52.4 | Not reported | 29.78 | 74.29 | Not reported |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 62.3 | Not reported | 52.33 | 71.50 | Not reported |
Source statistical analyses
- ci Lower Limit
- -15.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9390
- param Type
- Difference in Response Rates
- param Value
- -0.50
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 15.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 54.71
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- param Type
- Difference in Response Rates
- param Value
- 37.50
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -15.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.9390
- param Type
- Difference in Response Rates
- param Value
- -0.50
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 15.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 54.71
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- param Type
- Difference in Response Rates
- param Value
- 37.50
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75.78
- upper Limit
- 97.13
- value
- 89.7
- group Id
- OG001
- lower Limit
- 76.87
- upper Limit
- 97.28
- value
- 90.2
- group Id
- OG002
- lower Limit
- 53.47
- upper Limit
- 83.44
- value
- 70.0
- group Id
- OG003
- lower Limit
- 18.57
- upper Limit
- 49.13
- value
- 32.5
- group Id
- OG004
- lower Limit
- 68.30
- upper Limit
- 98.77
- value
- 90.0
- group Id
- OG005
- lower Limit
- 29.78
- upper Limit
- 74.29
- value
- 52.4
- group Id
- OG006
- lower Limit
- 52.33
- upper Limit
- 71.50
- value
- 62.3
- 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
- BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver \&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \& ELS, score=4 or 5, reduced UT than baseline (BL) \& residual mass of any size;residual UT\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.
- 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
- Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)
- title
- Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice