An observational study in Waldenstrom Macroglobulinemia, sponsored by BeiGene. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by BeiGene · Observational
This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.
524 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's planned enrollment of 111 is below the median of 150 across 40 observational studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 55 completed or terminated interventional studies of FDA-regulated products, 32 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with WM who are either already receiving or are planned to start treatment with zanubrutinib
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Bone marrow specimens with central MYD88 test results of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)
Drug: Zanubrutinib
Arm C: TN and R/R
Drug: Zanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Also known as: BGB-3111, Brukinsa
Major Response Rate (MRR)
MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)
Time frame: Up to approximately 4 years
VGPR+ Rate
VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)
Time frame: Up to approximately 5 years
Duration of Response (DOR)
DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first
Time frame: Up to approximately 5 years
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 5 years
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beigene.com
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Waldenstrom Macroglobulinemia →