TriangleNCT05023980 · OUTCOME
Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
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
- From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
What was measured
TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first.
Analysis population: All randomized participants.
Groups in this outcome
Arm A - Pirtobrutinib
Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
Arm B - Bendamustine Plus Rituximab
Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
| Group | Source count |
|---|---|
| Arm A - Pirtobrutinib | 141 |
| Arm B - Bendamustine Plus Rituximab | 141 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Pirtobrutinib | NA | Not reported | NA | NA | The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff. |
| Arm B - Bendamustine Plus Rituximab | NA | Not reported | NA | NA | The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff. |
Source statistical analyses
- ci Lower Limit
- 0.056
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.332
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- p Value Comment
- The 2-sided nominal p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.136
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.056
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.332
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.0001
- p Value Comment
- The 2-sided nominal p-value was calculated based on a stratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.136
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 141
- units
- Participants
- description
- TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A - Pirtobrutinib
- description
- Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
- id
- OG001
- title
- Arm B - Bendamustine Plus Rituximab
- param Type
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
- title
- Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7
Preserved source evidence · Not medical advice