以MRD驱动的Acalabrutinib和Lenalidomide加Rituximab (ALR) 或Obinutuzumab (ALO) 的初始治疗用于地幔细胞淋巴瘤
Jia Ruan1, David A Bond2, Bijal D Shah3
1Weill Cornell Medicine, New York, New York, United States.
Blood advances
|November 25, 2025
概括
这一第二阶段试验将acalabrutinib和lenalidomide与地幔细胞淋巴瘤 (MCL) 的抗CD20抗体结合起来,显示出高响应率和长期存活率. 最少残留疾病监测指导治疗,表明可行的,时间有限的治疗选择.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 膜细胞淋巴瘤 (MCL) 是一种侵略性的非霍奇金淋巴瘤.
- 对MCL的前线治疗策略正在发展,需要有效和耐受的治疗方案.
- 最小残留性疾病 (MRD) 监测正在成为淋巴瘤治疗中的预后和预测工具.
研究的目的:
- 评估acalabrutinib和lenalidomide与rituximab或obinutuzumab结合使用的疗效和安全性.
- 通过MRD监测来评估分子完整响应 (CR) 率.
- 为了探索瘤突变概况和无细胞DNA动态.
主要方法:
- 第二阶段,对acalabrutinib + lenalidomide + anti-CD20抗体 (rituximab或obinutuzumab) 的前性研究.
- 通过CAPP-Seq.使用clonoSEQ和cfDNA分析进行纵向MRD监测.
- 主要终点:在12个诱导周期后的分子CR;次要:安全性,反应,生存.
主要成果:
- 100%的ORR,83%的CR,67%的分子CR在ALR臂12个循环后;最佳的分子CR为83%.
- 在53个月的随访中位数,ALR的4年OS为91%,PFS为76%.
- TP53突变与较低的PFS相关 (p=0.026). ALO手臂显示90%的ORR,CR,分子CR与2年的OS/PFS在100%.
结论:
- 阿卡拉布鲁丁尼,莱纳利多米德和抗CD20抗体的组合是MCL的安全和有效的前线治疗方法.
- MRD 监测可以指导治疗决策,可能允许时间有限的治疗.
- 这种方案需要进一步研究针对MCL管理的响应调整的策略.
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