[Translation] A Phase III, randomized study comparing the efficacy and safety of MK-1026 with chemoimmunotherapy in patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma without TP53 aberrations (BELLWAVE-008)
主要目的:比较MK-1026与研究者选择的化学免疫治疗(氟达拉滨+环磷酰胺+利妥昔单抗[FCR]或苯达莫司汀+利妥昔单抗[BR])的PFS; 次要目的:在OS、ORR和DOR方面,比较MK-1026与研究者选择的化学免疫治疗(FCR或BR);评价MK-1026的安全性和耐受性。
[Translation] Primary objective: To compare the PFS of MK-1026 with that of investigator's choice of chemoimmunotherapy (fludarabine + cyclophosphamide + rituximab [FCR] or bendamustine + rituximab [BR]); Secondary objectives: To compare MK-1026 with that of investigator's choice of chemoimmunotherapy (FCR or BR) in terms of OS, ORR and DOR; To evaluate the safety and tolerability of MK-1026.