Blood:Ublituximab联合Umbralisib治疗复发性/难治性B细胞NHL和CLL的安全性评估

2019-10-02 MedSci MedSci原创

靶向CD20和PI3K(一种参与B细胞成熟的关键蛋白)可能是治疗B细胞恶性肿瘤的有效策略。研究人员开展一I/Ib期试验,评估二代化合物umbralisib(PI3K-δ抑制剂)联合ublituximab(抗CD20单克隆抗体[U2])用于慢性淋巴细胞 白血病(CLL)或非霍奇金淋巴瘤(NHL)的安全性。在I期剂量递增试验中,采用3+3的设计,摸索最大耐受剂量(MTD)。予以umbralisib&n

靶向CD20和PI3K(一种参与B细胞成熟的关键蛋白)可能是治疗B细胞恶性肿瘤的有效策略。研究人员开展一I/Ib期试验,评估二代化合物umbralisib(PI3K-δ抑制剂)联合ublituximab(抗CD20单克隆抗体[U2])用于慢性淋巴细胞 白血病(CLL)或非霍奇金淋巴瘤(NHL)的安全性。

在I期剂量递增试验中,采用3+3的设计,摸索最大耐受剂量(MTD)。予以umbralisib  600mg(CLL) 或900mg(NHL),持续12个疗程;予以ublituximab 800mg或1200mg(口服 1/日),或400-1200mg(在Ib期试验中,予以ublituximab 800-1200mg),直到病程进展、出现毒性或研究终止。

无论是在CLL还是NHL队列中,均未达到MTD,仅观察到1例剂量限制性毒性。ublituximab可见3级及以上的腹泻(8%)、肺炎(8%)或肝毒性(4%)。13%的患者因不良反应事件中断治疗,15%的患者减少umbralisib的用药剂量。

总体缓解率为46%,17%的患者获得完全缓解。中位缓解持续时间长达20个月(95% CI 11.3,未及)。综上所述,本联合方案的初步疗效尚可,值得进一步深入研究。

原始出处:

Matthew Lunning, et al.Ublituximab and Umbralisib in Relapsed/ Refractory B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia.Blood 2019 :blood.2019002118; doi: https://doi.org/10.1182/blood.2019002118

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    2020-09-14 snf701207
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    2019-10-04 yzh402
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    2019-10-04 freve

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