TriangleNCT02165397 · OUTCOME
Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54
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
- Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
What was measured
PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network \[NCCN\] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.
Analysis population: Intent to Treat population: all randomized/enrolled participants
Groups in this outcome
Ibrutinib + Rituximab
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
Placebo + Rituximab
Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
Open-Label Substudy: Ibrutinib
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
| Group | Source count |
|---|---|
| Ibrutinib + Rituximab | 75 |
| Placebo + Rituximab | 75 |
| Open-Label Substudy: Ibrutinib | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib + Rituximab | 68.0 | Not reported | 54.8 | 78.1 | Not reported |
| Placebo + Rituximab | 25.3 | Not reported | 15.3 | 36.6 | Not reported |
| Open-Label Substudy: Ibrutinib | 39.7 | Not reported | 22.3 | 56.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.148
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.420
- estimate Comment
- The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- The treatment effect was tested with a stratified log rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.250
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.148
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.420
- estimate Comment
- The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- The treatment effect was tested with a stratified log rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.250
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 54.8
- upper Limit
- 78.1
- value
- 68.0
- group Id
- OG001
- lower Limit
- 15.3
- upper Limit
- 36.6
- value
- 25.3
- group Id
- OG002
- lower Limit
- 22.3
- upper Limit
- 56.7
- value
- 39.7
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network \[NCCN\] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
- id
- OG000
- title
- Ibrutinib + Rituximab
- description
- Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
- id
- OG001
- title
- Placebo + Rituximab
- description
- Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
- id
- OG002
- title
- Open-Label Substudy: Ibrutinib
- param Type
- NUMBER
- population Description
- Intent to Treat population: all randomized/enrolled participants
- reporting Status
- POSTED
- time Frame
- Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
- title
- Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice