苯达莫司汀
奥比努图库单抗
医学
内科学
中性粒细胞减少症
慢性淋巴细胞白血病
发热性中性粒细胞减少症
胃肠病学
肿瘤科
白血病
临床研究阶段
美罗华
耐火材料(行星科学)
化疗
淋巴瘤
生物
天体生物学
作者
Julio Flores Bravo,Patricia Baltasar Tello,Esther González García,Eduardo Ríos Herranz,Ángel Ramírez Payer,Marie Castera,Diana Champ,Ángeles Medina Perez,Mercedes Gironella,Miguel Fernández Zarzoso,Rafael Forés,Julio Delgado,José A. García-Marco
标识
DOI:10.1080/10428194.2023.2216327
摘要
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.
科研通智能强力驱动
Strongly Powered by AbleSci AI