Recruiting

Zanubrutinib

Sponsor:

BeiGene

Code:

NCT05640102

Conditions

Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zanubrutinib

Study Details

Brief 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.

Conditions

Waldenstrom Macroglobulinemia

Study ID

NCT05640102

Start date

Mar 3, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

111 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1: MYD88 L265P mutation

Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)

Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype

Arm C: TN and R/R

Interventions

Zanubrutinib

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

Primary outcome measure

  • Major Response Rate (MRR) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Study Director

1-877-828-5568clinicaltrials@beigene.com

Locations

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805-2606

South Alabama Medical Science Foundation Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36604-1405

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-3012

Los Angeles Cancer Network (Lacn)

Recruiting

Glendale, California, United States, 91204-3640

Eisenhower Medical Center, Lucy Curci Cancer Center

Recruiting

Rancho Mirage, California, United States, 92270-3221

Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169-3321

More Information

Sponsor

BeiGene

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeiGene on 2026-08-07.