TriangleNCT02970318 · OUTCOME
Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
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 from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
What was measured
To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis. IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
Analysis population: Intent-to-treat population including all randomized participants
Groups in this outcome
Arm A: Acalabrutinib Monotherapy
Acalabrutinib 100 mg orally twice a day
Arm B: Investigators Choice
Idelalisib+Rituximab or Bendamustine + Retuximab
| Group | Source count |
|---|---|
| Arm A: Acalabrutinib Monotherapy | 155 |
| Arm B: Investigators Choice | 155 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Acalabrutinib Monotherapy | NA | Not reported | NA | NA | Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A. |
| Arm B: Investigators Choice | 16.5 | Not reported | 14.0 | 17.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.49
- estimate Comment
- Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.31
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.49
- estimate Comment
- Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.31
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 14.0
- upper Limit
- 17.1
- value
- 16.5
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 155
- units
- Participants
- description
- To evaluate the efficacy of acalabrutinib monotherapy (Arm A) compared with idelalisib/rituximab or bendamustine/rituximab (Arm B) based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson 2012) hereafter referred to as IWCLL 2008 criteria in subjects with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). As planned and reported in the interim clinical study report (dated 17 July 2019), because the study did cross the boundary at interim analysis. IRC assessments were discontinued after the interim analysis. All IRC-related efficacy analyses in this clinical study report were based on the interim analysis data cutoff date of 15 January 2019. All other efficacy analyses were based on the final analysis data cutoff date of 03 September 2021.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Acalabrutinib 100 mg orally twice a day
- id
- OG000
- title
- Arm A: Acalabrutinib Monotherapy
- description
- Idelalisib+Rituximab or Bendamustine + Retuximab
- id
- OG001
- title
- Arm B: Investigators Choice
- param Type
- MEDIAN
- population Description
- Intent-to-treat population including all randomized participants
- reporting Status
- POSTED
- time Frame
- IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up
- title
- Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice