Trial · NCT03053440
A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
NCT03053440, Phase 3, Completed, BeiGene; results first posted 2023-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM). Trials, record NCT03053440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03053440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
- NCT number
- NCT03053440
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Waldenström's Macroglobulinemia
- Interventions
- BGB-3111, Ibrutinib
- First posted
- 2017-02-15
- Last updated
- 2024-10-26
- Other registries' IDs
- eudract:2016-002980-33
- Results first posted
- 2023-06-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Up to approximately 2 years and 7 months | Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. |
| Secondary | Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | Up to approximately 2 years and 7 months | MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as ≥50% reduction of serum IgM from baseline. |
| Secondary | Duration of Response (DOR) as Assessed by IRC | Up to approximately 2 years and 7 months | DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline. |
| Secondary | DOR as Assessed by IRC: Event -Free Rate | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) | Estimated percentage of participants who were event-free based on Kaplan-Meier method. |
| Secondary | Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator | Up to approximately 5 years and 5 months | Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. |
| Secondary | DOR as Assessed by the Investigator | Up to approximately 5 years and 5 months | DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first |
| Secondary | DOR as Assessed by the Investigator: Event-Free Rate | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) | Estimated percentage of participants who were event-free based on Kaplan-Meier method. |
| Secondary | Progression Free Survival (PFS) as Assessed by the IRC | Up to approximately 2 years and 7 months | PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia \[IWWM criteria\]) or death, whichever occurs first |
| Secondary | PFS as Assessed by IRC: Event-Free Rate | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) | Estimated percentage of participants who were event-free based on Kaplan-Meier method |
| Secondary | PFS as Assessed by the Investigator | Up to approximately 5 years and 5 months | PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Up to approximately 2 years and 7 months | Intent To Treat (ITT) Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | Up to approximately 2 years and 7 months | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) as Assessed by IRC | Up to approximately 2 years and 7 months | ITT Analysis Set | Months | MEDIAN |
| SECONDARY | DOR as Assessed by IRC: Event -Free Rate | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator | Up to approximately 5 years and 5 months | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | DOR as Assessed by the Investigator | Up to approximately 5 years and 5 months | ITT Analysis Set | Months | MEDIAN |
| SECONDARY | DOR as Assessed by the Investigator: Event-Free Rate | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) as Assessed by the IRC | Up to approximately 2 years and 7 months | ITT Analysis Set | Months | MEDIAN |
| SECONDARY | PFS as Assessed by IRC: Event-Free Rate | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) | ITT Analysis Set | Percentage of Participants | NUMBER |
| SECONDARY | PFS as Assessed by the Investigator | Up to approximately 5 years and 5 months | ITT Analysis Set | Months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Arm A: Ibrutinib | 19.2 | 95% Confidence Interval 12.0 to 28.3 | Percentage of Participants | |
Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Arm B: Zanubrutinib | 28.4 | 95% Confidence Interval 19.9 to 38.2 | Percentage of Participants | |
| Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | Arm A: Ibrutinib | 77.8 | 95% Confidence Interval 68.3 to 85.5 | Percentage of Participants | |
| Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | Arm B: Zanubrutinib | 77.5 | 95% Confidence Interval 68.1 to 85.1 | Percentage of Participants | |
| Duration of Response (DOR) as Assessed by IRC | Arm A: Ibrutinib | NA | 95% Confidence Interval 8.0 to NA | Months | |
| Duration of Response (DOR) as Assessed by IRC | Arm B: Zanubrutinib | NA | 95% Confidence Interval NA to NA | Months | |
| DOR as Assessed by IRC: Event -Free Rate | Arm A: Ibrutinib | 12 Months | 87.9 | 95% Confidence Interval 77.0 to 93.8 | Percentage of Participants |
| DOR as Assessed by IRC: Event -Free Rate | Arm B: Zanubrutinib | 12 Months | 94.4 | 95% Confidence Interval 85.8 to 97.9 | Percentage of Participants |
| DOR as Assessed by IRC: Event -Free Rate | Arm A: Ibrutinib | 18 Months | 87.9 | 95% Confidence Interval 77.0 to 93.8 | Percentage of Participants |
| DOR as Assessed by IRC: Event -Free Rate | Arm B: Zanubrutinib | 18 Months | 85.2 | 95% Confidence Interval 71.7 to 92.6 | Percentage of Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Ibrutinib | 99 | |
| Overall Study | STARTED | Arm B: Zanubrutinib | 102 | |
| Overall Study | COMPLETED | Arm A: Ibrutinib | 0 | |
| Overall Study | COMPLETED | Arm B: Zanubrutinib | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Ibrutinib | 99 | |
| Overall Study | NOT COMPLETED | Arm B: Zanubrutinib | 102 |
Source ClinicalTrials.gov
Adverse events600
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 | Arm A: Ibrutinib | 22 | 98 | 48 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Zanubrutinib | 18 | 101 | 57 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm A: Ibrutinib | 5 | 98 | 6 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Arm B: Zanubrutinib | 3 | 101 | 3 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm A: Ibrutinib | 1 | 98 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Arm B: Zanubrutinib | 4 | 101 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A: Ibrutinib | 16 | 98 | 51 |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Zanubrutinib | 29 | 101 | 87 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Ibrutinib | 16 | 98 | 47 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Zanubrutinib | 15 | 101 | 61 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Ibrutinib | 19 | 99 |
| Total, all-cause mortality | Arm B: Zanubrutinib | 14 | 102 |
| Total, other adverse events | Arm A: Ibrutinib | 96 | 98 |
| Total, other adverse events | Arm B: Zanubrutinib | 99 | 101 |
| Total, serious adverse events | Arm A: Ibrutinib | 50 | 98 |
| Total, serious adverse events | Arm B: Zanubrutinib | 59 | 101 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Ibrutinib vs Arm B: Zanubrutinib: deaths from any cause | Trial comparisons |
| Arm A: Ibrutinib vs Arm B: Zanubrutinib: serious adverse events | Trial comparisons |
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/NCT03053440
GET https://conductscience.org/api/trials/v1/NCT03053440/results?page=2