Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma

Inclusion Criteria

• Age 18 years or older
• Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
• Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
• Current need for systemic therapy for MZL
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) of 0-2
• Life expectancy ≥ 6 months
• Adequate bone marrow function
• Adequate organ function
• Male and female participants must use highly effective methods of contraception Key

Exclusion Criteria

• Known transformation to aggressive lymphoma, eg, large cell lymphoma
• Clinically significant cardiovascular disease
• Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
• History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
• History of stroke or intracranial hemorrhage
• Severe or debilitating pulmonary disease
• Active fungal, bacterial and/or viral infection requiring systemic therapy
• Known central nervous system involvement by lymphoma
• Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
• Major surgery within 4 weeks of the first dose of study drug
• Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
• Pregnant or lactating women
• Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
• Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.