Chronic lymphocytic leukemia (Cll) aNti-CD20 aNtibODies fOr patieNts with COmOrbiDities

BaCKgROUnD CLL11 is a large randomized phase III trial investigating first-line chemoimmunotherapy in CLL patients with comorbidities. The final stage 1 analysis recently showed that GA101 plus Clb (GClb) or rituximab plus Clb (RClb) has superior efficacy to chemotherapy with Clb alone. This abstract presents the final stage 2 analysis with efficacy and safety results of the head-to-head comparison between GClb and RClb; at the pre-planned interim analysis, the primary endpoint was met early and the results were released by the independent data monitoring board (see Table 1). Treatment-naive CLL patients with a Cumulative Illness Rating Scale (CIRS) total score >6 and/or an estimated creatinine clearance (CrCl) <70 mL/min were eligible. Patients received Clb alone (0.5 mg/kg po d1; d15 q28 days, 6 cycles), GClb (100 mg iv d1, 900 mg d2, 1000 mg d8, d15 of cycle 1; 1000 mg d1 cycles 2–6), or RClb (375 mg/m IV d1 cycle 1, 500 mg/m d1 cycles 2–6). Primary endpoint was investigator-assessed progression-free survival (PFS). Response rates, minimal residual disease (MRD), and overall survival (OS) were key secondary efficacy endpoints.