Evaluating zanubrutinib for treating Waldenström Macroglobulinemia
A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia
This study is testing how well zanubrutinib works and how safe it is for people with Waldenström macroglobulinemia, especially those with certain genetic traits and from different backgrounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BeOne Medicines Industry-sponsored |
| Drugs / interventions | zanubrutinib |
| Locations | 8 sites (Huntsville, Alabama and 7 other locations) |
| Trial ID | NCT05640102 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of zanubrutinib in patients diagnosed with Waldenström macroglobulinemia, focusing on those with specific genetic mutations and from diverse racial and ethnic backgrounds. It utilizes a hybrid approach, combining retrospective and prospective data collection to create a comprehensive registry. The study will gather clinical profiles and treatment outcomes to enhance understanding of zanubrutinib's benefits in these populations.
Who should consider this trial
Good fit: Ideal candidates include individuals with a confirmed diagnosis of Waldenström macroglobulinemia who are currently being treated with or are planned to be prescribed zanubrutinib.
Not a fit: Patients with evidence of disease transformation or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of zanubrutinib for diverse patient groups with Waldenström macroglobulinemia.
How similar studies have performed: While this study focuses on a specific population, similar observational studies have shown promise in understanding treatment efficacy in diverse groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Huntsville, Alabama and 7 other locations
- Clearview Cancer Institute — Huntsville, Alabama, United States (Recruiting)
- South Alabama Medical Science Foundation Mitchell Cancer Institute — Mobile, Alabama, United States (Recruiting)
- City of Hope National Medical Center — Duarte, California, United States (Recruiting)
- Los Angeles Cancer Network (Lacn) — Glendale, California, United States (Recruiting)
- Eisenhower Medical Center, Lucy Curci Cancer Center — Rancho Mirage, California, United States (Recruiting)
- Hattiesburg Hematology and Oncology Clinic — Hattiesburg, Mississippi, United States (Recruiting)
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (Recruiting)
- Pan American Oncology Trials, Llc — Rio Piedras, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: clinicaltrials@beigene.com
- Phone: 1-877-828-5568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.