ClinicalTrials.gov record NCT05640102
Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a hybrid (retrospective and prospective) non-interventional registry collecting real-world data on zanubrutinib in adults with Waldenstrom macroglobulinemia. The study will describe clinical outcomes and safety across groups defined by MYD88 mutation status and by racial and ethnic minority groups. Data collection and follow-up may continue for up to about five years.
What it is studying. The study is gathering information on how zanubrutinib is used in routine care and measuring clinical outcomes (response rates, duration of response) and safety. It will compare these outcomes across MYD88 mutation cohorts (including L265P and non-L265P/MYD88 wildtype) and among racial and ethnic groups.
What the researchers hope to learn. To better describe the clinical profile, response rates (including Major Response Rate, VGPR+, and Overall Response Rate), duration of response, and treatment-emergent adverse events for zanubrutinib in people with Waldenstrom macroglobulinemia, including by MYD88 mutation status and racial/ethnic groups.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Zanubrutinib
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Clinical and definitive histologic diagnosis of WM
- Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL at the time of zanubrutinib initiation
- Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
- Bone marrow specimens with central MYD88 test results of:
- Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
- Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT
Exclusion criteria
- Evidence of disease transformation before the first dose of zanubrutinib
- Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
- Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
- Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a non‑interventional registry collecting past and future medical data for up to about 5 years. Participants continue zanubrutinib as prescribed by their treating physician; the study will collect medical records, treatment and safety information, and test results (for example serum IgM levels and central MYD88 bone marrow test results). Participation may require providing bone marrow specimen results to confirm MYD88 status. Concurrent enrollment in another therapeutic trial while receiving zanubrutinib must be reviewed with the study team.
How the study is structured. A non-interventional, observational registry that combines past (retrospective) and future (prospective) data. Doctors prescribe zanubrutinib as usual; the study collects medical-record information and follow-up data over time in defined cohorts. Target follow-up is up to approximately five years.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Puerto Rico, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Mar 3, 2023
- Primary completion
- December 2026 (estimated)
- Study completion
- December 2027 (estimated)
- Target enrollment
- 111 participants (estimated)
- Last updated on registry
- Aug 7, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- BeiGene
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Study Director 📞 1-877-828-5568 ✉ clinicaltrials@beigene.com
Participating sites (8)
- Clearview Cancer InstituteRecruiting
Huntsville, Alabama, 35805-2606 · United States
- South Alabama Medical Science Foundation Mitchell Cancer InstituteRecruiting
Mobile, Alabama, 36604-1405 · United States
- City of Hope National Medical CenterRecruiting
Duarte, California, 91010-3012 · United States
- Los Angeles Cancer Network (Lacn)Recruiting
Glendale, California, 91204-3640 · United States
- Eisenhower Medical Center, Lucy Curci Cancer CenterRecruiting
Rancho Mirage, California, 92270-3221 · United States
- Hattiesburg Hematology and Oncology ClinicActive Not Recruiting
Hattiesburg, Mississippi, 39401-7233 · United States
- Comprehensive Cancer Centers of NevadaRecruiting
Las Vegas, Nevada, 89169-3321 · United States
- Pan American Oncology Trials, LlcActive Not Recruiting
Rio Piedras, 00935 · Puerto Rico
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- interventional study
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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