Dataset from An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia

This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.

本项开放标签、多中心随机对照试验，对比了奥妥珠单抗（obinutuzumab，RO5072759；GA101）1000mg与2000mg在既往未接受治疗的慢性淋巴细胞白血病（Chronic Lymphocytic Leukemia, CLL）受试者中的疗效、安全性与药代动力学特征。受试者被随机分配接受最多8个周期（每周期28天）的奥妥珠单抗治疗：1000mg组采用静脉输注（intravenous [IV]）给药，方案为第1周期第1、8、15天给药，后续每个周期的第1天给药，直至完成最多8个周期；2000mg组同样采用静脉输注给药，方案为第1周期第1、8、15天给药，后续每个周期的第1天给药，直至完成最多8个周期。