TriangleNCT02257567 · OUTCOME
DLBCL Cohorts: PFS 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 randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)
What was measured
PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.
Analysis population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.
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 | 40 |
| Arm D (Phase II Randomization): BR in DLBCL | 40 |
| 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 C (Phase II Randomization): Pola+BR in DLBCL | 9.248 | Not reported | 6.045 | 13.930 | Not reported |
| Arm D (Phase II Randomization): BR in DLBCL | 3.713 | Not reported | 2.070 | 4.534 | Not reported |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 5.848 | Not reported | 2.103 | 11.893 | Not reported |
| Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL | 6.965 | Not reported | 5.092 | 9.823 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.66
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.39
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.66
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.39
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.045
- upper Limit
- 13.930
- value
- 9.248
- group Id
- OG001
- lower Limit
- 2.070
- upper Limit
- 4.534
- value
- 3.713
- group Id
- OG002
- lower Limit
- 2.103
- upper Limit
- 11.893
- value
- 5.848
- group Id
- OG003
- lower Limit
- 5.092
- upper Limit
- 9.823
- value
- 6.965
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 106
- units
- Participants
- description
- PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.
- 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.
- reporting Status
- POSTED
- time Frame
- From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)
- title
- DLBCL Cohorts: PFS 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