易布鲁替尼与venetoclax一起治疗复发/耐药慢性淋巴细胞白血病患者:一项II期研究
Mahesh Swaminathan1, Alessandra Ferrajoli2, Philip A Thompson3
1The University of Texas MD Anderson Cancer Center Houston, Texas United States.
Blood cancer discovery
|February 12, 2026
概括
易布鲁替尼和维尼托克拉克斯的联合治疗在复发性或耐药性慢性淋巴细胞白血病 (R/R CLL) 中显示出高疗效. 这种治疗实现了显著的完全缓解和不可检测的最小残留疾病率,为患者提供了一个有前途的选择.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 复发性或耐药性慢性淋巴细胞白血病 (R/R CLL) 是一个重大的临床挑战.
- 对于R/R CLL的标准治疗选择有局限性,需要新的治疗策略.
- 针对性治疗,如ibrutinib和venetoclax已经单独显示在CLL管理的承诺.
研究的目的:
- 评估ibrutinib和venetoclax联合治疗方案在R/RCLL患者中的疗效和安全性.
- 评估关键终点,包括完全缓解 (CR/CRi) 和不可检测的可测量的残留疾病 (U-MRD4) 率.
- 为了确定这种组合治疗后的长期无进展生存期 (PFS).
主要方法:
- 一项2期临床研究在2016年7月至2018年9月期间招募了80名R/R CLL患者.
- 患者接受了连续治疗:ibrutinib为3个周期,其次是ibrutinib加venetoclax为24个周期.
- 通过最佳CR/CRi,骨髓U-MRD4 (10-4灵敏度) 和长期PFS来评估有效性.
主要成果:
- 在79名接受治疗的患者中,67%的患者获得了最佳CR/CRi.
- 观察到骨髓U-MRD4的比例为61%.
- 随访时间中位数为95.5个月,估计的7年PFS率为63.3%.
结论:
- 易布鲁替尼和维尼托克拉克斯的组合表明,在R/RCLL中,CR/CRi和骨髓U-MRD4的高率.
- 这种疗法在复发性或耐药性疾病的患者中提供了持久的长期无进展生存.
- 这些发现支持ibrutinib和venetoclax组合作为R/R CLL的有效治疗策略.
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