Dataset from An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of
obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus
chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic
leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles
of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles
2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv
infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil
alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression
and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.