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Patients with chronic lymphocytic leukemia (CLL) who need therapy but are elderly or have significant comorbidities have limited options, as they are not suitable for fludarabine-based chemotherapy. For these patients, chlorambucil (CHL) has been the standard of care.
To determine the potential benefit of combining CHL with the anti-CD20 monoclonal antibody ofatumumab (OFA) in this setting, investigators conducted an industry-sponsored, multicenter, phase III trial (COMPLEMENT 1) in 447 previously untreated CLL patients (median age, 69 years) who were ineligible for fludarabine-based chemotherapy. Patients received 3 to 12 cycles of either CHL alone (daily for 7 days every 4 weeks) or with OFA (twice in cycle 1, and once in each cycle therea…