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Summary  Ibrutinib is effective in patients with chronic lymphocytic leukaemia ( CLL ); however, treatment resistance remains a problem. Ublituximab is a novel, glycoengineered anti‐ CD 20 monoclonal antibody with single‐agent activity in relapsed  CLL . We report the results of a phase 2 study evaluating combination therapy with ibrutinib and ublituximab in patients with relapsed or refractory  CLL . Patients received ibrutinib 420 mg once daily. Ublituximab was administered on days 1, 8 and 15 of cycle 1 followed by day 1 of cycles 2–6. Response assessments were completed at cycles 3 and 6; patients then continued on ibrutinib monotherapy per standard of care. Forty‐one of 45 enrolled patients were evaluable for efficacy. Safety was consistent with prior experience for each drug, with infusion reactions the most prevalent adverse event. Combination therapy resulted in an overall response rate ( ORR ) of 88% at 6 months. In the 20 patients with high‐risk features (17p or 11q deletions or   TP 53  mutation) and evaluable for efficacy, the  ORR  was 95%, with three patients (15%) achieving negative minimal residual disease. Median time to response was 8 weeks. Ublituximab in combination with ibrutinib resulted in rapid and high response rates. The long‐term clinical benefit of ublituximab will be defined by an ongoing phase 3 trial ( NCT  02301156).

british journal of haematology

Ublituximab ( TG ‐1101), a novel glycoengineered anti‐ CD 20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial