TriangleNCT01938001 · OUTCOME
Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
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
- From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm
What was measured
DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.
Analysis population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Groups in this outcome
Rituximab + Lenalidomide (R^2)
Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Rituximab + Placebo
Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
| Group | Source count |
|---|---|
| Rituximab + Lenalidomide (R^2) | 178 |
| Rituximab + Placebo | 180 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + Lenalidomide (R^2) | 25.3 | Not reported | 19.1 | 32.3 | Not reported |
| Rituximab + Placebo | 11.1 | Not reported | 6.9 | 16.6 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- statistical Comment
- Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0006
- statistical Comment
- Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.1
- upper Limit
- 32.3
- value
- 25.3
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 16.6
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
- id
- OG000
- title
- Rituximab + Lenalidomide (R^2)
- description
- Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
- id
- OG001
- title
- Rituximab + Placebo
- param Type
- NUMBER
- population Description
- The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
- reporting Status
- POSTED
- time Frame
- From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm
- title
- Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice