CLL-11: Designed to determine the superior anti-CD20 regimen for first-line CLL patients 1
GAZYVA (obinutuzumab) + Clb was evaluated against rituximab product + Clb in first-line CLL patients 1,6

- Primary endpoint: progression-free survival (PFS), as evaluated by an independent review committee
- Secondary endpoints: overall response rate, complete response rate, response duration, and minimal residual disease negativity
- The safety and efficacy of GAZYVA + Clb was
evaluated in a Stage I comparison of Arm 1 vs Arm 2 in 356 patients
and a Stage II comparison of Arm 2 vs Arm 3 in 663 patients
aAll patients required treatment according to NCI
criteria and had a life expectancy >6 months. 7
bPatients with creatinine clearance <30 mL/min or
inadequate liver function were excluded. 6
cEach dose of oral chlorambucil is 0.5 mg/kg of body
weight. Cycles 1-6: Days 1 and 15. 1
dEach dose of GAZYVA is 1,000 mg IV with the exception of
Cycle 1 Day 1 (100 mg) and Cycle 1 Day 2 (900 mg). Cycle 1: Days 1,
2, 8, and 15; Cycles 2-6: Day 1. 1
eEach dose of rituximab product is 500
mg/m2 IV with the exception of Cycle 1 Day 1 (375
mg/m2). Cycles 1-6: Day 1. 6