Hoffman-La Roche BO25323, A Prospective, Open-label, Multicenter, Randomized Phase III Trial to Compare the Efficacy and Safety of a Combined Regimen of Obinutuzumab and GDC-0199 (ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients with CLL and Coexisting Medical Conditions
Cancer - Leukemia
Principal Investigator: Nalini Janakiraman, MD
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and GDC-0199 versus obinutuzumab + chlorambucil (GCIb) in patients with chronic lymphocytic leukemia (CLL) and coexisting medical conditions.
Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria; CLL requiring treatment according to IWCLL criteria; adequate marrow function; adequate liver function; life expectancy greater than 6 months; agreement to use highly effective contraceptive methods per protocol.