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The PI3Kδ inhibitor idelalisib has single-agent activity in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). To assess response and safety of idelalisib in combination with the anti-CD20 monoclonal antibody rituximab in these patients, investigators conducted an industry-sponsored, phase III, multinational, randomized, placebo-controlled, double-blind trial involving 220 CLL patients (median age, 71; median Cumulative Illness Rating Scale score, 8). Eligible patients had progressive disease within 2 years of prior therapy and were clinically ineligible for cytotoxic chemotherapy.
Patients were randomized to rituximab intravenously (375 mg/m2 in week 1, then 500 mg/m2 weekly for 4 doses and 500 mg/m2 monthly for 3 dose…