Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

BeiGene

Status: Enrolling

Conditions: Waldenstrom Macroglobulinemia

Treatments: Drug: Zanubrutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT05640102

BGB-3111-402

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

111 participants in 2 patient groups

Cohort 1: MYD88 L265P mutation

Description:

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

Treatment:

Drug: Zanubrutinib

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

Description:

Arm C: TN and R/R

Treatment:

Drug: Zanubrutinib