Multicenter phase 2 trial of ibrutinib followed by ofatumumab consolidation in previouslye untreated patients with chronic lymphocytic leukemia

The multicenter phase 2 GELLC-7 trial in Spain evaluated ofatumumab consolidation after ibrutinib induction for previously untreated chronic lymphocytic leukemia (CLL). After twelve cycles of ibrutinib monotherapy, 5% of patients were in complete response (CR), 84% were in partial response (PR), and 7% were in partial response with lymphocytosis (PRL). Ibrutinib was continued, and patients not in CR received seven consolidation doses of ofatumumab. After consolidation 20 of 67 patients had improved from PR to CR, and all 6 patients with PRL had improved to PR. Eighty-five percent of patients completed 20 cycles of treatment, with a CR rate of 34% (in ITT-analysis 28.6%). Progression-free and overall survival rates at 48 months were 89.9% (95% CI 82.4-95.5) and 92.2% (85.3-97.1), respectively.