TriangleNCT02005471 · OUTCOME
PFS as Assessed by the IRC Using Standard iwCLL Guidelines
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
- Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
What was measured
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.
Analysis population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
Groups in this outcome
Bendamustine + Rituximab Main Study
Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Venetoclax + Rituximab Main Study
Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
| Group | Source count |
|---|---|
| Bendamustine + Rituximab Main Study | 195 |
| Venetoclax + Rituximab Main Study | 194 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 18.1 | Not reported | 15.8 | 22.3 | Not reported |
| Venetoclax + Rituximab Main Study | NA | Not reported | NA | NA | Median and corresponding 95% CI could not be estimated due to low number of participants with an event. |
Source statistical analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Log Rank
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.30
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.20
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.28
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.19
- statistical Method
- Log Rank
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.30
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Unstratified Analysis
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.20
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.8
- upper Limit
- 22.3
- value
- 18.1
- comment
- Median and corresponding 95% CI could not be estimated due to low number of participants with an event.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 194
- units
- Participants
- description
- PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- OG000
- title
- Bendamustine + Rituximab Main Study
- description
- Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
- id
- OG001
- title
- Venetoclax + Rituximab Main Study
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
- title
- PFS as Assessed by the IRC Using Standard iwCLL Guidelines
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice