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Rituximab (R) has been an integral component of chronic lymphocytic leukemia (CLL) therapy for the past 15 years, usually in combination with cytotoxic chemotherapy agents. In preclinical studies, the type-2 humanized monoclonal antibody obinutuzumab (Ob) demonstrated improved antibody-dependent cellular cytotoxicity and direct tumor cell death versus R. To evaluate Ob versus R in CLL patients with comorbidities, investigators conducted an industry-sponsored, phase III, multinational, randomized, three-arm trial involving 781 patients (median age, 73) with previously untreated CLL and serious coexisting illness (81% with >3 conditions; median Cumulative Illness Rating Scale score, 8).
Patients were randomized 1:2:2 to chlorambucil (C; 0.5 mg…