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RecruitingObservational

A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia

NCT ID: NCT05640102Sponsor: BeiGeneLast updated: 2026-03-04

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.

Arms & interventions

  • DrugZanubrutinib

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

Outcome measures

Primary

  • Major Response Rate (MRR)

    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)

    Time frame: Up to approximately 4 years

Secondary

  • VGPR+ Rate

    Time frame: Up to approximately 5 years

  • Overall Response Rate (ORR)

    Time frame: Up to approximately 5 years

  • Duration of Response (DOR)

    Time frame: Up to approximately 5 years

  • Number of Participants with Treatment-emergent Adverse Events

    Time frame: Up to approximately 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (7)

Clearview Cancer Institute

Huntsville, Alabama, 35805-2606

Recruiting

South Alabama Medical Science Foundation Mitchell Cancer Institute

Mobile, Alabama, 36604-1405

Recruiting

City of Hope National Medical Center

Duarte, California, 91010-3012

Recruiting

Los Angeles Cancer Network (Lacn)

Glendale, California, 91204-3640

Recruiting

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California, 92270-3221

Recruiting

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi, 39401-7233

Recruiting

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169-3321

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