Trial · NCT02180724
An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
NCT02180724, Phase 2, Active not recruiting, Acerta Pharma BV; results first posted 2020-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia. Trials, record NCT02180724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180724
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia
- NCT number
- NCT02180724
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Acerta Pharma BV
- Conditions
- Waldenström Macroglobulinemia (WM)
- Interventions
- Acalabrutinib (ACP-196), Acalabrutinib (ACP-196)
- First posted
- 2014-07-03
- Last updated
- 2026-09-14
- Other registries' IDs
- eudract:2014-003212-36
- Results first posted
- 2020-04-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle). | 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. |
| Primary | Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria | Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle). | 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. |
| Secondary | Progression-free Survival (PFS) of Acalabrutinib by Investigator | Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle). | 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. |
| Secondary | Overall Survival (OS) of Acalabrutinib by Investigator | Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27. | Outcome Measure was pre-specified to summarize data per investigator assessment with respect to subject's vital/survival status is presented in the RRF and irrespective of iWWM 3rd or 6th criteria. Kaplan-Meier (K-M) estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive by the given time over all patients at risk. |
| Secondary | Summary of Duration of Response (DOR) | Primary analysis occur when all subjects have completed Cycle 27 or have exit the study | DOR is defined as the interval from the first documentation of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minor Response (MR) to the earlier of the first documentation of definitive PD or death from any cause. The summary statistics are provided for DOR. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle). | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) of Acalabrutinib by Investigator | Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle). | 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. | percentage of subjects | NUMBER |
| SECONDARY | Overall Survival (OS) of Acalabrutinib by Investigator | Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27. | 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. | Percentage of subjects | NUMBER |
| SECONDARY | Summary of Duration of Response (DOR) | Primary analysis occur when all subjects have completed Cycle 27 or have exit the study | 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. | months | MEAN |
| PRIMARY | Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 3rd Criteria | Up to approximately 3.8 years. Data cut at when last patient has completed Cycle 27 (28 days per Cycle). | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Previously Treated (N=92) | ORR 6th IWWM criteria (CR+VGPR+PR+MR) | 87 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Treatment Naive (N=14) | ORR 6th IWWM criteria (CR+VGPR+PR+MR) | 13 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Previously Treated (N=92) | CR (6th IWWM criteria) | 4 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Treatment Naive (N=14) | CR (6th IWWM criteria) | 0 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Previously Treated (N=92) | VGPR (6th IWWM criteria) | 21 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Treatment Naive (N=14) | VGPR (6th IWWM criteria) | 0 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Previously Treated (N=92) | PR (6th IWWM criteria) | 52 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Treatment Naive (N=14) | PR (6th IWWM criteria) | 10 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Previously Treated (N=92) | MR (6th) | 10 | Participants | |
| Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator Per IWWM 6th Criteria | Treatment Naive (N=14) | MR (6th) | 2 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Previously Treated (PT) Total | 92 | |
| Overall Study | STARTED | Treatment Naive (TN) Cohort 1 | 14 | |
| Overall Study | 200 mg QD | Previously Treated (PT) Total | 7 | |
| Overall Study | 200 mg QD | Treatment Naive (TN) Cohort 1 | 1 | |
| Overall Study | 100 mg BID | Previously Treated (PT) Total | 85 | |
| Overall Study | 100 mg BID | Treatment Naive (TN) Cohort 1 | 13 | |
| Overall Study | COMPLETED | Previously Treated (PT) Total | 0 | |
| Overall Study | COMPLETED | Treatment Naive (TN) Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Previously Treated (PT) Total | 92 | |
| Overall Study | NOT COMPLETED | Treatment Naive (TN) Cohort 1 | 14 |
Source ClinicalTrials.gov
Adverse events3,348
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Cohort 1 | 11 | 87 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Cohort 2 | 0 | 5 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Total | 11 | 92 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Naive (TN) Cohort 1 | 0 | 13 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Naive (TN) Cohort 2 | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Naive (TN) Total | 0 | 14 | 0 |
| other | Cold type haemolytic anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Cohort 1 | 1 | 87 | 1 |
| other | Cold type haemolytic anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Cohort 2 | 0 | 5 | 0 |
| other | Cold type haemolytic anaemia | Blood and lymphatic system disorders | Previously Treated (PT) Total | 1 | 92 | 1 |
| other | Cold type haemolytic anaemia | Blood and lymphatic system disorders | Treatment Naive (TN) Cohort 1 | 0 | 13 | 0 |
1 to 10 of 3,348Source ClinicalTrials.gov
See all 3,348 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Previously Treated (PT) Cohort 1 | 26 | 87 |
| Total, all-cause mortality | Previously Treated (PT) Cohort 2 | 0 | 5 |
| Total, all-cause mortality | Previously Treated (PT) Total | 26 | 92 |
| Total, all-cause mortality | Treatment Naive (TN) Cohort 1 | 1 | 13 |
| Total, all-cause mortality | Treatment Naive (TN) Cohort 2 | 0 | 1 |
| Total, all-cause mortality | Treatment Naive (TN) Total | 1 | 14 |
| Total, other adverse events | Previously Treated (PT) Cohort 1 | 87 | 87 |
| Total, other adverse events | Previously Treated (PT) Cohort 2 | 5 | 5 |
| Total, other adverse events | Previously Treated (PT) Total | 92 | 92 |
| Total, other adverse events | Treatment Naive (TN) Cohort 1 | 13 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02180724
GET https://conductscience.org/api/trials/v1/NCT02180724/results?page=2