Proposed rituximab biosimilar BCD‐020 versus reference rituximab for treatment of patients with indolent non‐Hodgkin lymphomas: An international multicenter randomized trial
作者: Irina V. PoddubnayaSergey M. AlekseevKamil D. KaplanovLes M. LukavetskyyGrigoriy B. RekhtmanTuphan K. DolaiV. Satya Suresh AttiliCarlos D. BermúdezAleksandr A. IsaevEkaterina V. ChernyaevaRoman A. Ivanov
作者单位: 1Russian Medical Academy of Continuous Professional Education Moscow Russia
2 Leningrad Regional Oncology Center Saint Petersburg Russia
3 Volgograd Regional Clinical Oncologic Dispensary Volgograd Russia
4 Hematology Department Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine Lviv Ukraine
5 Hematology Department Khmelnytskyi Regional Hospital Khmelnytskyi Ukraine
6 Hematology Department NRS Medical College and Hospital Kolkata India
7 Department of Internal Medicine SVS Medical College, Mehabubnagar and Continental Hospitals Hyderabad India
8 CIOSAD Clinic and National Institute of Cancerology Bogota Colombia
9 JSC BIOCAD Saint Petersburg Russia
刊名: Hematological Oncology, 2020, Vol.38 (1), pp.67-73
来源数据库: Wiley Journal
DOI: 10.1002/hon.2693
关键词: BiosimilarIndolent lymphomaRituximab
原始语种摘要: Abstract(#br)BCD‐020 is a proposed rituximab biosimilar, which has shown high similarity to rituximab in quality and nonclinical studies in vitro and in vivo.(#br)International multicenter clinical trial was conducted to compare efficacy and safety of BCD‐020 and reference rituximab in adult (older than 18 years) patients with indolent lymphomas (follicular lymphoma grade 1‐2, splenic marginal zone lymphoma, and nodal marginal zone lymphoma). Pharmacokinetics, pharmacodynamics, and immunogenicity were also studied.(#br)Patients with no previous biologic treatment for lymphoma were randomly assigned 1:1 to receive BCD‐020 or comparator 375 mg/m2 for 4 weeks.(#br)Primary study outcome was day 50 overall response rate defined as complete or partial remission. Equivalence range was −20% to...
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关键词翻译
关键词翻译
  • indolent 无痛的
  • lymphoma 淋巴瘤
  • BCD Binary-Coded Data
  • reference 基准电压源
  • trial 试验
  • immunogenicity 致免疫性
  • comparator 比较器
  • efficacy 效验
  • treatment 处理
  • neutralizing 中和