Actively Recruiting

Age: 18Years +
All Genders
NCT05640102

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

Led by BeiGene · Updated on 2026-03-04

111

Participants Needed

8

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical and definitive histologic diagnosis of WM
  • Measurable disease with serum immunoglobulin M (IgM) level > 0.5 g/dL at zanubrutinib start
  • Started, currently treated, or planned to be treated with zanubrutinib for WM
  • Bone marrow specimens with central MYD88 test results for:
    1. Cohort 1: MYD88 L265P mutation; enrollment of treatment-naive participants will stop when required numbers per racial and ethnic group are met
    2. Cohort 2: non-L265P MYD88 mutations or MYD88 wild-type
Not Eligible

You will not qualify if you...

  • Evidence of disease transformation before first zanubrutinib dose
  • Evidence of other non-Hodgkin lymphoma subtypes
  • Prior or concurrent active malignancy within 2 years before first zanubrutinib dose, except if deemed not to affect safety or efficacy interpretation
  • Concurrent participation in another therapeutic clinical study while receiving zanubrutinib unless approved by Medical Monitor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Clearview Cancer Institute

Huntsville, Alabama, United States, 35805-2606

Actively Recruiting

2

South Alabama Medical Science Foundation Mitchell Cancer Institute

Mobile, Alabama, United States, 36604-1405

Actively Recruiting

3

City of Hope National Medical Center

Duarte, California, United States, 91010-3012

Actively Recruiting

4

Los Angeles Cancer Network (Lacn)

Glendale, California, United States, 91204-3640

Actively Recruiting

5

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California, United States, 92270-3221

Actively Recruiting

6

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi, United States, 39401-7233

Actively Recruiting

7

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169-3321

Actively Recruiting

8

Pan American Oncology Trials, Llc

Rio Piedras, Puerto Rico, 00935

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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