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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy 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 Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Cohort 1: MYD88 L265P mutation Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)
  • Drug: Zanubrutinib
    Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
    Other names:
    • BGB-3111
    • Brukinsa
Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype Arm C: TN and R/R
  • Drug: Zanubrutinib
    Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
    Other names:
    • BGB-3111
    • Brukinsa

Recruiting Locations

Tulane Cancer Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
BeiGene

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.