在日本患有复发/耐药地幔细胞淋巴瘤的患者中,研究ibrutinib加venetoclax的第二阶段研究
Hideki Goto1, Satoshi Ito2, Masahiro Kizaki3
1Department of Hematology, Hokkaido University Hospital, Kita-14, Nishi-5, Kita-Ku, Sapporo-Shi, Hokkaido, Japan. hidekigt@med.hokudai.ac.jp.
International journal of clinical oncology
|December 29, 2023
概括
易布鲁替尼和威尼托克拉克斯联合治疗在患有复发性或耐火性地幔细胞淋巴瘤 (MCL) 的日本患者中显示出高疗效. 该疗法显示出显著的反应率和有利的安全性,为R/R MCL提供了有前途的选择.
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:
- 膜细胞淋巴瘤 (MCL) 在初始治疗后经常复发.
- 对复发性或耐火性 (R/R) MCL 的有效疗法至关重要.
研究的目的:
- 评估ibrutinib和venetoclax在日本患者的疗效,安全性和药理动力学,这些患者患有R/R MCL.
- 作为主要终点,确定完整响应率 (CR).
主要方法:
- 第二阶段,单臂研究 (M20-075) 涉及R/R MCL的日本患者.
- 在5周的加大后,患者每天接受IBRUTINIB (560毫克) 和VENETOCLAX (400毫克),长达104周.
- 终点包括CR,整体响应率 (ORR),响应持续时间 (DOR),不可检测的最小残留疾病 (uMRD),无进展生存率 (PFS),整体生存率 (OS) 和安全.
主要成果:
- 83%的CR和ORR观察到在每一协议设置 (n=12).
- 所有可评估的患者都获得了不可检测的最小残留疾病 (uMRD).
- 没有达到中位数的DOR,PFS和OS;中性质衰竭是最常见的TEAE等级≥3.
结论:
- 易布鲁替尼加维内托克拉克斯在日本R/R MCL患者中显示出高响应率.
- 组合疗法显示了耐受性良好的安全性.
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