TriangleNCT02005471 · OUTCOME
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to approximately 8 years 5 months
What was measured
Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.Percentages are rounded off.
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
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 8.2 | Not reported | 4.76 | 12.98 | Not reported |
| Venetoclax + Rituximab Main Study | 26.3 | Not reported | 20.24 | 33.07 | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 0.5 | Not reported | 0.01 | 2.82 | Not reported |
| Venetoclax + Rituximab Main Study | 1.5 | Not reported | 0.32 | 4.45 | Not reported |
nPR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 6.2 | Not reported | 3.22 | 10.50 | Not reported |
| Venetoclax + Rituximab Main Study | 3.6 | Not reported | 1.46 | 7.29 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | 52.8 | Not reported | 45.56 | 59.99 | Not reported |
| Venetoclax + Rituximab Main Study | 61.9 | Not reported | 54.62 | 68.72 | Not reported |
Source statistical analyses
- ci Lower Limit
- 17.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.33
- estimate Comment
- 95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in Response Rates
- param Value
- 25.61
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 3.97
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.37
- estimate Comment
- OR was estimated using logistic regression model. The 95% CI was computed using Wald test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 7.81
Complete source fields
- analyses
- ci Lower Limit
- 17.88
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 33.33
- estimate Comment
- 95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- param Type
- Difference in Response Rates
- param Value
- 25.61
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- 3.97
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.37
- estimate Comment
- OR was estimated using logistic regression model. The 95% CI was computed using Wald test.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Odds Ratio (OR)
- param Value
- 7.81
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.76
- upper Limit
- 12.98
- value
- 8.2
- group Id
- OG001
- lower Limit
- 20.24
- upper Limit
- 33.07
- value
- 26.3
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.01
- upper Limit
- 2.82
- value
- 0.5
- group Id
- OG001
- lower Limit
- 0.32
- upper Limit
- 4.45
- value
- 1.5
- title
- CRi
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.22
- upper Limit
- 10.50
- value
- 6.2
- group Id
- OG001
- lower Limit
- 1.46
- upper Limit
- 7.29
- value
- 3.6
- title
- nPR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.56
- upper Limit
- 59.99
- value
- 52.8
- group Id
- OG001
- lower Limit
- 54.62
- upper Limit
- 68.72
- value
- 61.9
- title
- PR
- denoms
- counts
- group Id
- OG000
- value
- 195
- group Id
- OG001
- value
- 194
- units
- Participants
- description
- Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.Percentages are rounded off.
- 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
- NUMBER
- 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 approximately 8 years 5 months
- title
- Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice