TriangleNCT02180724 · OUTCOME
Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle).
What was measured
ORR defined as the rate of subjects achieving a Miner Response (MR) or better including complete response (CR), very good partial response (VGPR), partial response (PR) and MR; The definition of responses are evaluated by investigators using both Modified 6th criteria (refer to protocol table 4-2 , 4-3) and Modified 3rd International Workshop of Waldenström Macroglobulinemia (IWWM) criteria (refer to protocol table 4-4 and table 4-5 for definition). For Modified 6th criteria, MR is defined as (1) monoclonal IgM protein is detectable, (2) no new signs or symptoms of active disease, (3) and patient has \>=25% but \< 50% reduction in serum monoclonal IgM level from baseline. PR and VGPR both require (1) and (2) as MR, but PR also requires the \>=50% and \<90% reduction in serum monoclonal IgM level as well as reduction in extramedullary disease. VGPR requires \>= 90% reduction in serum IgM and complete resolution of extramedullary disease.
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=92
Treatment Naive (N=14)
100 mg BID N= 14
| Group | Source count |
|---|---|
| Previously Treated (N=92) | 92 |
| Treatment Naive (N=14) | 14 |
Reported measurements
ORR 3rd IWWM criteria (CR+VGPR+PR+MR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 87 | Not reported | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 13 | Not reported | Not reported | Not reported | Not reported |
CR (IWWM 3rd criteria)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 2 | Not reported | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 0 | Not reported | Not reported | Not reported | Not reported |
VGPR (IWWM 3rd criteria)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 38 | Not reported | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 1 | Not reported | Not reported | Not reported | Not reported |
PR (IWWM 3rd criteria)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 35 | Not reported | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 10 | Not reported | Not reported | Not reported | Not reported |
MR (IWWM 3rd criteria)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Previously Treated (N=92) | 12 | Not reported | Not reported | Not reported | Not reported |
| Treatment Naive (N=14) | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 13
- title
- ORR 3rd IWWM criteria (CR+VGPR+PR+MR)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- CR (IWWM 3rd criteria)
- categories
- measurements
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 1
- title
- VGPR (IWWM 3rd criteria)
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 10
- title
- PR (IWWM 3rd criteria)
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 2
- title
- MR (IWWM 3rd criteria)
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- ORR defined as the rate of subjects achieving a Miner Response (MR) or better including complete response (CR), very good partial response (VGPR), partial response (PR) and MR; The definition of responses are evaluated by investigators using both Modified 6th criteria (refer to protocol table 4-2 , 4-3) and Modified 3rd International Workshop of Waldenström Macroglobulinemia (IWWM) criteria (refer to protocol table 4-4 and table 4-5 for definition). For Modified 6th criteria, MR is defined as (1) monoclonal IgM protein is detectable, (2) no new signs or symptoms of active disease, (3) and patient has \>=25% but \< 50% reduction in serum monoclonal IgM level from baseline. PR and VGPR both require (1) and (2) as MR, but PR also requires the \>=50% and \<90% reduction in serum monoclonal IgM level as well as reduction in extramedullary disease. VGPR requires \>= 90% reduction in serum IgM and complete resolution of extramedullary disease.
- groups
- description
- 100 mg BID N=92
- id
- OG000
- title
- Previously Treated (N=92)
- description
- 100 mg BID N= 14
- id
- OG001
- title
- Treatment Naive (N=14)
- param Type
- COUNT_OF_PARTICIPANTS
- 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 when last patient has completed Cycle 27 (28 days per Cycle).
- title
- Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice