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.
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
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
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
Adult participants with WM who are either already receiving or are planned to start treatment with zanubrutinib
Cohort
Other
Zanubrutinib
DrugDosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
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)
VGPR+ Rate
VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR
Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)
Duration of Response (DOR)
DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first
Number of Participants with Treatment-emergent Adverse Events
