肿瘤
词汇介绍
拓展阅读
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,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.
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