TriangleNCT03112174 · OUTCOME
Time to Next Treatment (TTNT) (Randomization Phase and Treatment-Naive Arm)
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
- For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)
What was measured
TTNT is defined as the duration from the date of randomization (Randomization Phase) or date of first dose of study treatment (Treatment-Naive Arm) to the start date of any anti-lymphoma treatment subsequent to study treatment. Post-treatment stem cell transplantation, chimeric antigen receptor (CAR) T-cell therapy, or other cellular therapies were not considered subsequent anti-cancer treatments for participants responding to the study treatment (CR or PR).
Analysis population: All randomized and all enrolled treatment-naïve participants
Groups in this outcome
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
Treatment-naive Open-label Arm
Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
| Group | Source count |
|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 134 |
| Randomization Phase: Ibrutinib + Placebo | 133 |
| Treatment-naive Open-label Arm | 78 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | NA | Not reported | 48.0 | NA | Not estimable due to the small number of events |
| Randomization Phase: Ibrutinib + Placebo | 35.4 | Not reported | 24.7 | 49.8 | Not reported |
| Treatment-naive Open-label Arm | NA | Not reported | NA | NA | Not estimable due to the small number of events |
Source statistical analyses
- ci Lower Limit
- 0.369
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.792
- estimate Comment
- Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0013
- p Value Comment
- P value is from stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.541
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.369
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.792
- estimate Comment
- Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0013
- p Value Comment
- P value is from stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.541
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Not estimable due to the small number of events
- group Id
- OG000
- lower Limit
- 48.0
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 24.7
- upper Limit
- 49.8
- value
- 35.4
- comment
- Not estimable due to the small number of events
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 134
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 78
- units
- Participants
- description
- TTNT is defined as the duration from the date of randomization (Randomization Phase) or date of first dose of study treatment (Treatment-Naive Arm) to the start date of any anti-lymphoma treatment subsequent to study treatment. Post-treatment stem cell transplantation, chimeric antigen receptor (CAR) T-cell therapy, or other cellular therapies were not considered subsequent anti-cancer treatments for participants responding to the study treatment (CR or PR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG000
- title
- Randomization Phase: Ibrutinb + Venetoclax
- description
- Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG001
- title
- Randomization Phase: Ibrutinib + Placebo
- description
- Participants were treated with ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg).
- id
- OG002
- title
- Treatment-naive Open-label Arm
- param Type
- MEDIAN
- population Description
- All randomized and all enrolled treatment-naïve participants
- reporting Status
- POSTED
- time Frame
- For an overall median time on study of 61.34 months (Randomization Phase) and 40.51 months (Treatment-Naïve arm)
- title
- Time to Next Treatment (TTNT) (Randomization Phase and Treatment-Naive Arm)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice