A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia
Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia.
Studies have shown that drugs in combination with fludarabine have shown more effectiveness
than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide
combination offers potentially a more effective therapy, without additional toxicity.
The objective of this study is to determine the effect of ofatumumab added to fludarabine
and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded
previously to therapy but later develop progressive disease and require additional therapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
GSK Clinical Trials
United States: Institutional Review Board
|GSK Investigational Site||St. Louis, Missouri 63141|
|GSK Investigational Site||Germantown, Tennessee 38138|