Abstract：
GABRIELL was a phase II single-arm study to evaluate the efficacy and safety of obinutuzumab plus bendamustine for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Seventy-two patients with active disease received treatment for up to six 28-day cycles. Overall response rate was 78.6% with a median progression-free survival (PFS) of 26 months, and overall survival (OS) not reached at the end of follow-up (36 months). Undetectable measurable residual disease (≤0.01%; 36.4% in bone marrow and 53.4% in peripheral blood) correlated with a significantly longer PFS and OS (vs. >0.01). Common grade ≥3 adverse events (76.4%) were neutropenia (58.3%), thrombocytopenia (26.4%) and febrile neutropenia (11.1%). TP53 disruption was the only independent predictive factor for response (Hazard ratio; HR: 0.228). Unmutated immunoglobulin heavy chain variable region (HR: 16.061) was a negative prognostic factor for PFS. In conclusion, the combination of obinutuzumab plus bendamustine is an active and generally adequately-tolerated treatment for R/R CLL.
摘要：
GABRIELL是一项II期单臂研究，旨在评估奥比妥珠单抗联合苯达莫司汀治疗复发性/难治性（R/R）慢性淋巴细胞白血病（CLL）的疗效和安全性。72例活动性疾病患者接受了长达6个28天周期的治疗。总有效率为78.6%，中位无进展生存期（PFS）为26个月，随访结束时（36个月）未达到总生存期（OS）。无法检测到的残余疾病（≤0.01％；骨髓中的36.4％和外周血中的53.4％）与明显更长的PFS和OS相关（vs.>0.01）。常见的≥3级不良事件（76.4%）为中性粒细胞减少（58.3%），血小板减少症（26.4%）和发热性中性粒细胞减少症（11.1%）。TP53中断是反应的唯一独立预测因素（危险比；HR：0.228）。未突变的免疫球蛋白重链可变区（HR：16.061）是PFS的负面预后因素。总之,奥比妥珠单抗联合苯达莫司汀是R/RCLL的一种积极且普遍耐受的治疗方法.
