Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Condition: Marginal Zone Lymphoma; MZL
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Zanubrutinib
Intervention description: Zanubrutinib at a dose of 160 mg orally twice a day (BID)
Intervention MeSH terms: Zanubrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BGB-3111; Zanubrutinib

Summary:

      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).
    

Eligibility criteria:

        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 partial response or documented progressive disease (PD) after, the
             most recent systemic treatment

          4. Current need for systemic therapy for MZL

          5. Measurable disease by computed tomography (CT) or magnetic resonance imaging (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's 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.