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Patients with relapsed or refractory chronic lymphoid leukemia (CLL) who are older than 70 or have comorbid illness, del 17p, or short response to immunochemotherapy have poor outcomes with available treatments. To evaluate the effectiveness of the oral Bruton tyrosine kinase inhibitor ibrutinib in this patient population, investigators compared the agent with the anti-CD20 monoclonal antibody ofatumumab in an industry-sponsored, multicenter, open-label, phase III trial (RESONATE).
A total of 391 patients received ibrutinib (420 mg daily) as ongoing therapy or standard ofatumumab (administered by intravenous infusion) for 24 weeks. The protocol was modified during the trial to allow crossover from ofatumumab to ibrutinib. Patients had receiv…