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).
Primary Outcomes
Measure: Overall response rate (ORR) determined by independent central review Time: Up to 3 years
Secondary Outcomes
Measure: ORR by investigator assessment Time: Up to 3 years
Measure: Progression-free survival (PFS) Time: Up to 3 years
Measure: Overall survival (OS) Time: Up to 3 years
Measure: Duration of response (DOR) Time: Up to 3 years
Measure: Time to response (TTR) Time: Up to 3 years
Measure: Participant-reported outcomes (PROs) as measured by the EuroQo EQ-5D-5L questionnaire Time: Up to 3 years
Measure: PROs as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Time: Up to 3 years
Measure: Occurrence and severity of treatment-emergent adverse events (safety and tolerability) Time: Up to 3 years