Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2017-04-24
Target enrollment:
Participant gender:
Summary
The purpose of this study was to confirm the clinical benefit observed in the pivotal
registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP)
required that a randomized study be conducted in CLL patients with bulky
fludarabine-refractory disease as a specific obligation for grant of conditional approval for
ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians'
choice of therapy.