TriangleNCT05023980 · OUTCOME
Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58
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 up to 37 months
What was measured
A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
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
- 0.291
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.863
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.011
- 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
- 0.501
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.291
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.863
- estimate Comment
- The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.011
- 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
- 0.501
- 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
- A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.
- 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 up to 37 months
- title
- Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice