TriangleNCT02165397 · OUTCOME
Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment.
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
TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit. As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are 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 | 87.4 | Not reported | 77.2 | 93.3 | Not reported |
| Placebo + Rituximab | 29.4 | Not reported | 18.2 | 41.6 | Not reported |
| Open-Label Substudy: Ibrutinib | 64.6 | Not reported | 44.1 | 79.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.049
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.212
- estimate Comment
- Hazard ratio is estimated using a stratified Cox regression model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- P-value is from a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.102
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.049
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.212
- estimate Comment
- Hazard ratio is estimated using a stratified Cox regression model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- P-value is from a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.102
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.2
- upper Limit
- 93.3
- value
- 87.4
- group Id
- OG001
- lower Limit
- 18.2
- upper Limit
- 41.6
- value
- 29.4
- group Id
- OG002
- lower Limit
- 44.1
- upper Limit
- 79.2
- value
- 64.6
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit. As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are 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
- Time to Next Treatment (TnT) Time From the Date of Randomization to the Start Date of Any Subsequent WM Treatment.
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice