Five-Year Follow-Up Of Safety And Efficacy Of A Phase Iii Randomized Trial Of Ofatumumab Therapy Versus Physicians' Choice In Patients With Bulky Fludarabine Refractory Chronic Lymphocytic Leukemia

Background: In 2014, a planned interim analysis of an open-label, two-arm, randomized, phase III study of ofatumumab (OFA) vs physicians' choice (PC) treatment (most patients received rituximab-, alemtuzumab-, alkylator-, or fludarabine-based therapies) in patients with bulky fludarabine-refractory chronic lymphocytic leukemia (BFR CLL) was performed to assess the effectiveness of OFA in the time-period prior to administering small molecule kinase inhibitors. The study did not meet its primary endpoint of progression-free survival (PFS) as assessed by the independent review committee (median PFS 5.4 months vs 3.6 months; hazard ratio [HR]=0.79, 95% confidence interval [CI]: 0.50, 1.24; p=0.268). Here, we report the 5-year follow-up of the study.