TriangleNCT02475681 · OUTCOME
Progression-free Survival by IRC Assessment Arm A Versus Arm C
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
- IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
What was measured
To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib monotherapy (Arm C) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.
Analysis population: Intent to Treat (ITT)
Groups in this outcome
Arm A: Obinutuzumab in Combination With Chlorambucil
Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.
Arm C: Acalabrutinib Monotherapy
Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
| Group | Source count |
|---|---|
| Arm A: Obinutuzumab in Combination With Chlorambucil | 177 |
| Arm C: Acalabrutinib Monotherapy | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Obinutuzumab in Combination With Chlorambucil | 22.6 | Not reported | 20.2 | 27.6 | Not reported |
| Arm C: Acalabrutinib Monotherapy | NA | Not reported | 34.2 | NA | The median PFS for Arm C was not reached (Range = 0.0+ to 39.5+ months). "+" indicates a value from a censored subject. |
Source statistical analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.30
- group Description
- The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.2
- statistical Comment
- Stratified by randomization stratification factors as recorded in IXRS
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.30
- group Description
- The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.2
- statistical Comment
- Stratified by randomization stratification factors as recorded in IXRS
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.2
- upper Limit
- 27.6
- value
- 22.6
- comment
- The median PFS for Arm C was not reached (Range = 0.0+ to 39.5+ months). "+" indicates a value from a censored subject.
- group Id
- OG001
- lower Limit
- 34.2
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 177
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib monotherapy (Arm C) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A: Obinutuzumab in Combination With Chlorambucil
- description
- Acalabrutinib (ACP-196) will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
- id
- OG001
- title
- Arm C: Acalabrutinib Monotherapy
- param Type
- MEDIAN
- population Description
- Intent to Treat (ITT)
- reporting Status
- POSTED
- time Frame
- IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.
- title
- Progression-free Survival by IRC Assessment Arm A Versus Arm C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice