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ublituximab

肿瘤

关键词肿瘤 药物 单克隆抗体

词汇介绍

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解析

ublituximab

释    义   n. 是经由TG Therapeutics研发的一款新型单克隆抗体

例    句   In addition to treating with 1 g of daily intravenous methylprednisolone, we infused a single dose of 450 mg of ublituximab within 5 days of relapse onset. 除了每天静脉注射1克甲基强的松龙外,我们还在复发开始的5天内注射了450毫克的ublituximab。

概述

Ublituximab(TG-1101)是经由TG Therapeutics研发的一款新型单克隆抗体,是一种新型糖工程化抗CD20单克隆抗体,靶向成熟B淋巴细胞上CD20抗原的特异性表位。用于治疗包括慢性淋巴细胞白血病在内的一系列B细胞增殖性疾病(如淋巴瘤)。目前,该药正处于III期临床开发,用于多发性硬化症(MS)和慢性淋巴细胞白血病(CLL)的治疗。该药正在5项后期临床研究中评估治疗癌症(如CLL、NHL)和非癌症(如MM)适应症。目前,TG公司正在等待关键数据。III期UNITY-CL

Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukaemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial复制标题

Ublituximab,umbralisib和ibrutinib在慢性淋巴细胞白血病和非霍奇金淋巴瘤患者中的耐受性和活性: 1期剂量递增和扩展试验

发表时间:2019-02-01

影响因子:12.0

作者: Loretta J Nastoupil

期刊:Lancet Haematol

We did an open-label, phase 1 study with dose-escalation and dose-expansion phases, at five centres in the USA. Eligible patients were aged 18 years or older with histologically confirmed lymphocytic leukaemia or relapsed or refractory B-cell non-Hodgkin lymphoma, had measurable disease, adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. Patients with known CNS lymphoma, active hepatitis B or C infection, or HIV were excluded. In the dose-escalation cohort, patients were treated in cycles of 28 days with escalating doses of oral umbralisib (400, 600, or 800 mg) and fixed doses of intravenous ublituximab (900 mg) and oral ibrutinib (420 mg for patients with chronic lymphocytic leukaemia; 560 mg for patients with B-cell non-Hodgkin lymphoma) in a standard 3 × 3 design until disease progression or intolerance. In the dose-expansion phase, patients were given the recommended dose of the drug combination as determined from the dose-escalation phase. The primary endpoints were safety, dose-limiting toxicities, and the maximum tolerated dose of umbralisib, when given in combination with ublituximab and ibrutinib. Safety was assessed in patients who received at least one dose of study drug; activity was assessed in all patients who had at least one post-treatment efficacy measurement.

译文

我们在美国的五个中心进行了一个开放标签的1期研究,包括剂量递增和剂量扩展两个阶段。符合条件的患者年龄在18岁或以上,经组织学证实为淋巴细胞性白血病或复发或难治性B细胞非霍奇金淋巴瘤,可测量的疾病,适当的器官功能,并且东部合作肿瘤小组(ECOG)的表现状态为2以下。排除患有已知中枢神经系统淋巴瘤,活动性乙型或丙型肝炎感染或艾滋病毒的患者。在剂量递增队列中,以递增剂量的口服umbralisib(400、600或800 mg)和固定剂量的静脉注射ublituximab(900 mg)和口服ibrutinib(对于慢性病患者为420 mg)以28天为周期进行治疗淋巴细胞性白血病;标准3-×3设计,对于B细胞非霍奇金淋巴瘤患者为560毫克),直到疾病进展或不耐受为止。在剂量增加阶段,根据剂量增加阶段确定的推荐剂量的药物组合给予患者。与ublituximab和ibrutinib并用时,主要终点是安全性,剂量限制性毒性和umbralisib的最大耐受剂量。评估接受至少一剂研究药物的患者的安全性;在所有接受过至少一项治疗后功效测量的患者中评估其活性。