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Observational Study of Zanubrutinib for Waldenström Macroglobulinemia

This study is looking at how well and how safely zanubrutinib works for people with Waldenström Macroglobulinemia (WM), a rare type of cancer affecting white blood cells. Researchers want to understand its effects in different groups, including those with specific genetic changes (mutations) and from diverse racial and ethnic backgrounds. You might be able to join if you have WM, have a certain level of a protein called serum immunoglobulin M (IgM), and are already taking or planning to take zanubrutinib. The main goal is to see how many people have a major response to the treatment over about four years. The study status is currently unclear, and it plans to include 111 participants.

Study design
This is an observational study, meaning researchers will collect information about your treatment as prescribed by your doctor. It is a hybrid study, looking at past and future information, and is not a traditional clinical trial where treatments are assigned.
What's involved
Dosing and treatment duration are decided by your doctor. The study will collect data from your medical records.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Major Response Rate, will be measured for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05640102

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

Recruiting
Not specifiedAges 18+Observational
BeiGene
~111 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Zanubrutinib

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Response Rate (MRR)
Measured over Up to approximately 4 years

Conditions

Waldenstrom Macroglobulinemia

Explore related trials

Waldenstrom MacroglobulinemiaMYD88 Gene

NCT05640102

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope National Medical Center

    Duarte, Californiano site contact published

    Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabamano site contact published

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevadano site contact published

    Recruiting

  • Eisenhower Medical Center, Lucy Curci Cancer Center

    Rancho Mirage, Californiano site contact published

    Recruiting

  • Los Angeles Cancer Network (Lacn)

    Glendale, Californiano site contact published

    Recruiting

  • South Alabama Medical Science Foundation Mitchell Cancer Institute

    Mobile, Alabamano site contact published

    Recruiting

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippino site contact published

    Active, not recruiting

  • Pan American Oncology Trials, Llc

    Rio Piedras, Puerto Ricono site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeiGene

Who to contact

Study Director
[email protected]
1-877-828-5568
Email the study team

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Eligibility criteria

Inclusion

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:

Exclusion

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

What this trial measures

  • Major Response Rate (MRR)Up to approximately 4 years

    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)