CLL-11: Designed to determine the superior anti-CD20 regimen for first-line CLL patients 1

GAZYVA + Clb was evaluated against rituximab + Clb in first-line CLL patients 1,6

GAZYVA CLL-11 Trial Schema Image
  • 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 1000 mg 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 is 500 mg/m2 with the exception of Cycle 1 Day 1 (375 mg/m2). Cycles 1-6: Day 1. 6