TriangleNCT02005471 · OUTCOME
PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
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 8 years 5 months)
What was measured
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator 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.
Analysis population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
Groups in this outcome
Bendamustine + Rituximab 17p Del. Population
Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.
Venetoclax + Rituximab 17p Del. Population
Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.
| Group | Source count |
|---|---|
| Bendamustine + Rituximab 17p Del. Population | 46 |
| Venetoclax + Rituximab 17p Del. Population | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab 17p Del. Population | 15.4 | Not reported | 10.0 | 21.0 | Not reported |
| Venetoclax + Rituximab 17p Del. Population | 47.9 | Not reported | 37.4 | 59.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.57
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Stratified Analysis; Stratification factor: geographic region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.35
- statistical Method
- Log Rank
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- 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
- 0.35
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.57
- estimate Comment
- Hazard ratio was estimated by Cox regression model.
- group Description
- Stratified Analysis; Stratification factor: geographic region.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.35
- statistical Method
- Log Rank
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- 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
- 0.35
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.0
- upper Limit
- 21.0
- value
- 15.4
- group Id
- OG001
- lower Limit
- 37.4
- upper Limit
- 59.9
- value
- 47.9
- denoms
- counts
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 46
- units
- Participants
- description
- PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received bendamustine at a dose of 70 mg/m\^2 via 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. Only participants with 17p deletion as identified by FISH test were included.
- id
- OG000
- title
- Bendamustine + Rituximab 17p Del. Population
- description
- Participants were initially placed on a venetoclax ramp-up period of 4 to 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet 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. Only participants with 17p deletion as identified by FISH test were included.
- id
- OG001
- title
- Venetoclax + Rituximab 17p Del. Population
- param Type
- MEDIAN
- population Description
- Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
- reporting Status
- POSTED
- time Frame
- Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
- title
- PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice