Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib
 (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
This is a Phase 2, open-label study of zanubrutinib in approximately 65 participants with R/R
 MZL. The study will evaluate efficacy, as measured by overall response rate, safety and
 tolerability.
Key Inclusion Criteria:

 1. Age 18 years or older

 2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal
 subtypes

 3. 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 PR or documented progressive disease (PD) after, the most recent
 systemic treatment

 4. Current need for systemic therapy for MZL

 5. Measurable disease by CT or MRI

 6. Eastern Cooperative Oncology Group (ECOG) of 0-2

 7. Life expectancy ≥ 6 months

 8. Adequate bone marrow function

 9. Adequate organ function

 10. Male and female participants must use highly effective methods of contraception

 Key Exclusion Criteria:

 1. Known transformation to aggressive lymphoma, eg, large cell lymphoma.

 2. Clinically significant cardiovascular disease

 3. 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

 4. 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

 5. History of stroke or intracranial hemorrhage

 6. Severe or debilitating pulmonary disease

 7. Active fungal, bacterial and/or viral infection requiring systemic therapy

 8. Known central nervous system involvement by lymphoma

 9. Known infection with HIV, or serologic status reflecting active viral hepatitis B
 (HBV) or viral hepatitis C (HCV) infection

 10. Major surgery within 4 weeks of the first dose of study drug

 11. Prior treatment with a Bruton tyrosine kinase (BTK) inhibitor

 12. Pregnant or lactating women

 13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or
 inducer

 14. Concurrent participation in another therapeutic clinical trial

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.