TriangleNCT02180724 · OUTCOME
Progression-free Survival (PFS) of Acalabrutinib by Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle).
What was measured
Kaplan-Meier (K-M) estimates of the PFS assessments and its 95% confidence interval are provided using both modified 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive or have not progressed by the given time over all patients at risk. Per 6th IWWM criteria, the progressive disease is defined as \>= 25% increase in serum IgM level with an absolute increase of at least 500 mg/dL from lowest nadir (requires confirmation on at least 2 consecutive measurements at least 4 weeks apart) and/or progression of clinical features attributable to the disease. Per modified 3rd IWWM criteria, besides IgM requirement as 6th criteria, it could also includes progression of clinically significant disease related symptoms and/or death from any cause or initiation of a new anti-neoplastic therapy.
Analysis population: In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
Groups in this outcome
Previously Treated (N=92)
100 mg BID N=87 + 200 mg QD N= 5
Treatment Naive (N=14)
100 mg BID N= 13 + 200 mg QD N=1
| Group | Source count |
|---|---|
| Previously Treated (N=92) | 92 |
| Treatment Naive (N=14) | 14 |
Reported measurements
K-M Point Est. for PFS by 6th IWWM criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 81.9 | Not reported | 72.1 | 88.5 | Not reported |
| Treatment Naive (N=14) | 90.0 | Not reported | 47.3 | 98.5 | Not reported |
K-M Point Est. for PFS by 3rd IWWM criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 81.9 | Not reported | 72.1 | 88.5 | Not reported |
| Treatment Naive (N=14) | 90.0 | Not reported | 47.3 | 98.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.1
- upper Limit
- 88.5
- value
- 81.9
- group Id
- OG001
- lower Limit
- 47.3
- upper Limit
- 98.5
- value
- 90.0
- title
- K-M Point Est. for PFS by 6th IWWM criteria
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.1
- upper Limit
- 88.5
- value
- 81.9
- group Id
- OG001
- lower Limit
- 47.3
- upper Limit
- 98.5
- value
- 90.0
- title
- K-M Point Est. for PFS by 3rd IWWM criteria
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Kaplan-Meier (K-M) estimates of the PFS assessments and its 95% confidence interval are provided using both modified 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive or have not progressed by the given time over all patients at risk. Per 6th IWWM criteria, the progressive disease is defined as \>= 25% increase in serum IgM level with an absolute increase of at least 500 mg/dL from lowest nadir (requires confirmation on at least 2 consecutive measurements at least 4 weeks apart) and/or progression of clinical features attributable to the disease. Per modified 3rd IWWM criteria, besides IgM requirement as 6th criteria, it could also includes progression of clinically significant disease related symptoms and/or death from any cause or initiation of a new anti-neoplastic therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 100 mg BID N=87 + 200 mg QD N= 5
- id
- OG000
- title
- Previously Treated (N=92)
- description
- 100 mg BID N= 13 + 200 mg QD N=1
- id
- OG001
- title
- Treatment Naive (N=14)
- param Type
- NUMBER
- population Description
- In the original protocol, previously treated subjects were planned to be randomized 1:1 into 2 cohorts: Cohort 1 to receive Acala 100 mg BID for 28 days and Cohort 2 to receive Acala 200 mg once daily (QD) for 28 days. After enrollment started, the dose regimen was amended. The 200 mg QD dose was eliminated, and subjects who were enrolled under the original protocol and received treatment with 200 mg QD were switched to 100 mg BID. Results are combined.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle).
- title
- Progression-free Survival (PFS) of Acalabrutinib by Investigator
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
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Preserved source evidence · Not medical advice