A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Intolerant of Prior Treatment with Ibrut
This is a Phase 2, multicenter, single-arm, monotherapy study of zanubrutinib in approximately 60 patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were intolerant to prior ibrutinib treatment as defined per protocol. Patients must have achieved a response to prior ibrutinib therapy of at least SD at enrollment. Patients who have received intervening anticancer therapy between ibrutinib and zanubrutinib are excluded. The primary endpoint is safety of zanubrutinib as measured by the frequency and severity of selected events (ie, diarrhea; myalgia/arthralgia; hypertension; fatigue; muscle spasms; rash; atrial fibrillation and hemorrhage, excluding central nervous system bleeding).