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Clinical Trials in the USA / NCT05640102
Recruiting Observational

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

NCT05640102 · tracked via the Priya Life Science USA tracker
Sponsor
BeiGene
Phase
Observational
Started
2023-03-03
Last updated
2026-08-07

Condition(s) studied

Waldenstrom Macroglobulinemia

Investigational drug(s) / intervention(s)

Zanubrutinib

Zanubrutinib: Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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: 1. 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 2. 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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
South Alabama Medical Science Foundation Mitchell Cancer Institute Mobile Alabama Recruiting
City of Hope National Medical Center Duarte California Recruiting
Los Angeles Cancer Network (Lacn) Glendale California Recruiting
Eisenhower Medical Center, Lucy Curci Cancer Center Rancho Mirage California Recruiting
Hattiesburg Hematology and Oncology Clinic Hattiesburg Mississippi Active Not Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada Recruiting
Pan American Oncology Trials, Llc Rio Piedras Puerto Rico Active Not Recruiting

On this site

📄 Brukinsa (zanubrutinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05640102 on ClinicalTrials.gov ↗ ← All trials in the USA