NCT02787239已完成3 期
Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Overall Response Rate (ORR)
研究概览
简要总结
Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated CD20-positive DLBCL confirmed.
- •IPI score of 1 to 2, Stage I ~ IV, Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
- •ECOG performance status of 0 to
- •More than 6 months life expectancy.
- •At least one measurable lesion: For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
- •18 years to 70 years; Male or female patients.
排除标准
- •Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
- •Known allergic reactions against any component of CHOP regimen.
- •Previous treatment for NHL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
- •History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
- •Prior use of any monoclonal antibody within 3 months.
- •Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.
研究组 & 干预措施
Rituximab
Active Comparator
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
干预措施: Rituximab (Drug)
HLX01
Experimental
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
干预措施: HLX01 (Drug)
HLX01
Experimental
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
干预措施: CHOP (Drug)
Rituximab
Active Comparator
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
干预措施: CHOP (Drug)
结局指标
主要结局
Percentage of Participants With Overall Response Rate (ORR)
时间窗: 18 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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