The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
| Study Arm | Population | Intervention | Comparison | Outcome |
|---|---|---|---|---|
Cohort 1 |
Patients intolerant to ibrutinib |
Zanubrutinib |
None |
Primary Endpoint: Investigator-assessed recurrence and change in severity of ibrutinib or acalabrutinib intolerance events |
Cohort 2 |
Patients intolerant to acalabrutinib alone or to acalabrutinib and ibrutinib |
Zanubrutinib |
None |
Primary Endpoint: Investigator-assessed recurrence and change in severity of ibrutinib or acalabrutinib intolerance events Key Secondary Endpoints: ORR, DCR, DoR, PFS, and HRQoL |
