Trial · NCT03332173
Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
NCT03332173, Phase 2, Completed, BeiGene; results first posted 2022-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM). Trials, record NCT03332173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03332173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
- NCT number
- NCT03332173
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Waldenström's Macroglobulinemia (WM)
- Interventions
- Zanubrutinib
- First posted
- 2017-11-06
- Last updated
- 2024-10-26
- Results first posted
- 2022-03-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Response Rate (MRR) as Assessed by the Independent Review Committee | Up to approximately 1 year and 9 months | MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria |
| Secondary | Progression Free Survival (PFS) | Up to approximately 1 year and 9 months | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria |
| Secondary | PFS: Event-free Rate | Up to approximately 1 year and 9 months | Progression/death event-free rates were estimated by Kaplan-Meier method with 95% confidence intervals (CIs) estimated using Greenwood's formula |
| Secondary | Overall Response Rate (ORR) | Up to approximately 1 year and 9 months | ORR is defined as the percentage of participants with a minor, partial, very good partial, and complete response, as assessed by an independent review committee using modified Owen's criteria |
| Secondary | Duration of Major Response (DOMR) | Up to approximately 1 year and 9 months | DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria |
| Secondary | DOMR: Event-free Rate | Up to approximately 1 year and 9 months | DOMR event-free rates were estimated by Kaplan-Meier method with 95% CIs estimated using Greenwood's formula |
| Secondary | Number of Participants With Resolution of Treatment-precipitating Symptoms | Up to approximately 1 year and 9 months | Number of participants with resolution of treatment-precipitating symptoms, defined as any resolution (from "Yes" at baseline to "No" at any postbaseline point onwards during study) of the indications for initiation of therapy in WM signs and symptoms evaluation. |
| Secondary | Number of Participants With an Anti-lymphoma Effect | Up to approximately 1 year and 9 months | Number of participants with an anti-lymphoma effect, defined as any reduction during the course of study in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by computed tomography scan as assessed by an independent review committee; lymphadenopathy is defined as any node with longest diameter (LDi) \> 1.5 cm and splenomegaly is defined as vertical spleen length \> 13 cm |
| Secondary | Number of Participants With Adverse Events | Up to approximately 3 years and 5 months | Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Response Rate (MRR) as Assessed by the Independent Review Committee | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Months | MEDIAN |
| SECONDARY | PFS: Event-free Rate | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Percentage of participants | NUMBER |
| SECONDARY | Duration of Major Response (DOMR) | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Months | MEDIAN |
| SECONDARY | DOMR: Event-free Rate | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Resolution of Treatment-precipitating Symptoms | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Anti-lymphoma Effect | Up to approximately 1 year and 9 months | Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Up to approximately 3 years and 5 months | The Safety Analysis Set included all participants who received ≥ 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Response Rate (MRR) as Assessed by the Independent Review Committee | Zanubrutinib | 69.8 | 95% Confidence Interval 53.87 to 82.82 | Percentage of participants | |
| Progression Free Survival (PFS) | Zanubrutinib | NA | 95% Confidence Interval 16.53 to NA | Months | |
| PFS: Event-free Rate | Zanubrutinib | 6 months | 89.8 | 95% Confidence Interval 75.1 to 96.1 | Percentage of participants |
| PFS: Event-free Rate | Zanubrutinib | 9 months | 87.0 | 95% Confidence Interval 71.5 to 94.4 | Percentage of participants |
| PFS: Event-free Rate | Zanubrutinib | 12 months | 77.8 | 95% Confidence Interval 60.2 to 88.3 | Percentage of participants |
| Overall Response Rate (ORR) | Zanubrutinib | 79.1 | 95% Confidence Interval 63.96 to 89.96 | Percentage of participants | |
| Duration of Major Response (DOMR) | Zanubrutinib | NA | 95% Confidence Interval 13.77 to NA | Months | |
| DOMR: Event-free Rate | Zanubrutinib | 6 months | 96.2 | 95% Confidence Interval 75.7 to 99.4 | Percentage of participants |
| DOMR: Event-free Rate | Zanubrutinib | 9 months | 87.0 | 95% Confidence Interval 64.7 to 95.6 | Percentage of participants |
| DOMR: Event-free Rate | Zanubrutinib | 12 months | 87.0 | 95% Confidence Interval 64.7 to 95.6 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zanubrutinib | 44 | |
| Overall Study | COMPLETED | Zanubrutinib | 0 | |
| Overall Study | NOT COMPLETED | Zanubrutinib | 44 |
Source ClinicalTrials.gov
Adverse events107
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 | Zanubrutinib | 8 | 44 | |
| other | Leukopenia | Blood and lymphatic system disorders | Zanubrutinib | 3 | 44 | |
| other | Neutropenia | Blood and lymphatic system disorders | Zanubrutinib | 2 | 44 | |
| other | Angina pectoris | Cardiac disorders | Zanubrutinib | 2 | 44 | |
| other | Cataract | Eye disorders | Zanubrutinib | 3 | 44 | |
| other | Conjunctival haemorrhage | Eye disorders | Zanubrutinib | 2 | 44 | |
| other | Ocular discomfort | Eye disorders | Zanubrutinib | 2 | 44 | |
| other | Retinal haemorrhage | Eye disorders | Zanubrutinib | 3 | 44 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Zanubrutinib | 3 | 44 | |
| other | Constipation | Gastrointestinal disorders | Zanubrutinib | 2 | 44 |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zanubrutinib | 7 | 44 |
| Total, other adverse events | Zanubrutinib | 44 | 44 |
| Total, serious adverse events | Zanubrutinib | 25 | 44 |
Source ClinicalTrials.gov
Papers2
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/NCT03332173
GET https://conductscience.org/api/trials/v1/NCT03332173/events?page=2