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

Last updated: March 3, 2026
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Lymphoproliferative Disorders

Waldenstrom Macroglobulinemia

Treatment

Zanubrutinib

Clinical Study ID

NCT05640102
BGB-3111-402
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Clinical and definitive histologic diagnosis of WM

  • Measurable disease, as defined by a serum immunoglobulin M (IgM) level > 0.5 g/dL atthe time of zanubrutinib initiation

  • Started treatment with zanubrutinib, has been treated with zanubrutinib, or isplanned 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 stoppedin each racial and ethnic participant group when the required numbers ofparticipants in the group are met

  2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

Exclusion

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 ofzanubrutinib, except for malignancies that, in the investigator's opinion, will notobscure the interpretation of safety or efficacy results

  • Concurrent participation in another therapeutic clinical study while receivingzanubrutinib, although the participant may be eligible depending on the status ofthe interventional study after discussion with the Medical Monitor or designee on anindividual basis

Study Design

Total Participants: 111
Treatment Group(s): 1
Primary Treatment: Zanubrutinib
Phase:
Study Start date:
March 03, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Pan American Oncology Trials, Llc

    Rio Piedras, 00935
    Puerto Rico

    Active - Recruiting

  • Pan American Oncology Trials, Llc

    Rio Piedras 4829037, 00935
    Puerto Rico

    Site Not Available

  • Auxilio Mutuo Cancer Center

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Auxilio Mutuo Cancer Center

    San Juan 4568127, 00917
    Puerto Rico

    Site Not Available

  • Clearview Cancer Institute

    Huntsville, Alabama 35805-2606
    United States

    Active - Recruiting

  • Mitchell Cancer Institute

    Mobile, Alabama 36604-1405
    United States

    Site Not Available

  • South Alabama Medical Science Foundation Mitchell Cancer Institute

    Mobile, Alabama 36604-1405
    United States

    Active - Recruiting

  • Clearview Cancer Institute

    Huntsville 4068590, Alabama 4829764 35805-2606
    United States

    Site Not Available

  • Mitchell Cancer Institute

    Mobile 4076598, Alabama 4829764 36604-1405
    United States

    Active - Recruiting

  • South Alabama Medical Science Foundation Mitchell Cancer Institute

    Mobile 4076598, Alabama 4829764 36604-1405
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010-3012
    United States

    Active - Recruiting

  • Los Angeles Cancer Network (Lacn)

    Glendale, California 91204-3640
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067-2011
    United States

    Site Not Available

  • Eisenhower Medical Center, Lucy Curci Cancer Center

    Rancho Mirage, California 92270-3221
    United States

    Active - Recruiting

  • Pacific Central Coast Health Centers, Slo Oncology and Hematology Health Center

    San Luis Obispo, California 93401-7068
    United States

    Site Not Available

  • Pacific Central Coast Health Centers, Mission Hope Medical Oncology

    Santa Maria, California 93454-5909
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte 5344147, California 5332921 91010-3012
    United States

    Site Not Available

  • Los Angeles Cancer Network (Lacn)

    Glendale 5352423, California 5332921 91204-3640
    United States

    Site Not Available

  • Eisenhower Medical Center, Lucy Curci Cancer Center

    Rancho Mirage 5386015, California 5332921 92270-3221
    United States

    Site Not Available

  • Brcr Medical Center, Inc

    Plantation, Florida 33322-5426
    United States

    Site Not Available

  • Brcr Medical Center, Inc

    Plantation 4168782, Florida 4155751 33322-5426
    United States

    Site Not Available

  • Tulane Cancer Center

    New Orleans, Louisiana 70112-2618
    United States

    Site Not Available

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi 39401-7233
    United States

    Active - Recruiting

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg 4429295, Mississippi 4436296 39401-7233
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169-3321
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas 5506956, Nevada 5509151 89169-3321
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932-1049
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960-6136
    United States

    Site Not Available

  • Clinical Research Alliance, Inc

    Westbury, New York 11590-5119
    United States

    Site Not Available

  • Clinical Research Alliance, Inc

    Westbury 5144040, New York 5128638 11590-5119
    United States

    Site Not Available

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