Ofatumumab (Ofa) Vs. Physician'S Choice (Pc) Of Therapy In Patients (Pts) With Bulky Fludarabine Refractory (Bfr) Chronic Lymphocytic Leukaemia (Cll): Results Of The Phase Iii Study Omb114242

OFA was approved for the treatment of fludarabine and alemtuzumab refractory CLL on the basis of a single-arm study which also included pts with BFR CLL. This open label, randomized, Phase III study of OFA or PC treatment in pts with CLL refractory to fludarabine and with bulky lymphadenopathy (at least one lymph node > 5 cm) was conducted to confirm the results of OFA in BFR pts and also through a 2nd randomization to compare extended OFA (12 months) vs. approved regimen of OFA (6 months). PC was considered an appropriate comparator for these pts given the lack of a consensus around standard of care treatment for this difficult-to-treat population.