TriangleNCT02005471 · OUTCOME
Duration of Responses (DOR) as Assessed by the Investigator Using 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
- From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
What was measured
DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. 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 without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.
Analysis population: Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.
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 | 132 |
| Venetoclax + Rituximab Main Study | 181 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 19.1 | Not reported | 16.1 | 23.6 | Not reported |
| Venetoclax + Rituximab Main Study | 53.6 | Not reported | 49.1 | 57.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.1
- upper Limit
- 23.6
- value
- 19.1
- group Id
- OG001
- lower Limit
- 49.1
- upper Limit
- 57.0
- value
- 53.6
- denoms
- counts
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 181
- units
- Participants
- description
- DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. 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 without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.
- 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
- Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.
- reporting Status
- POSTED
- time Frame
- From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
- title
- Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice