Evaluating zanubrutinib for treating Waldenström Macroglobulinemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Comprehensive Cancer Centers of Nevada
  Las Vegas, Nevada, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beigene.com
• Phone: 1-877-828-5568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zanubrutinib with bendamustine and rituximab for untreated Waldenström macroglobulinemia

  This treatment will try zanubrutinib together with bendamustine and rituximab to see if it produces deep responses in people with untreated Waldenström macroglobulinemia.

  Recruiting at 5 sites Phase 2 Massachusetts General Hospital · Denver, Colorado and 4 other locations · NCT06561347

• Comparing venetoclax and rituximab to ibrutinib and rituximab for treating Waldenstrom's macroglobulinemia

  This study is testing whether a new combination of venetoclax and rituximab works better than the standard treatment of ibrutinib and rituximab for people with Waldenstrom's macroglobulinemia who haven't been treated before.

  Recruiting at 106 sites Phase 2 National Cancer Institute (NCI) · Tucson, Arizona and 149 other locations · NCT04840602

• Zanubrutinib plus Lenalidomide for frail elderly with newly diagnosed PCNSL

  This study tests whether a combination of zanubrutinib and lenalidomide can help frail elderly patients with newly diagnosed primary CNS lymphoma.

  Recruiting Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07839247

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• MRD-guided Zanubrutinib + Sonrotoclax in new high-risk CLL/SLL

  This trial tests a time-limited, MRD-guided combination therapy with zanubrutinib and sonrotoclax for adults up to 75 with previously untreated high-risk CLL/SLL.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07671378

• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.