Rituximab biosimilar(Eden Biologics, Inc.)

主要目的：在DLBCL初治患者中，比较两组用药治疗6个周期后的总缓解率。 次要目的：在初治DLBCL患者中，比较两组用药1.治疗的安全性；2.6个周期后完全缓解率、1年无进展生存率、1年无事件生存率和1年总生存率；3.免疫原性；4.分析在两组用药患者中的群体药代动力学特征及发生输液相关反应患者的药代动力学特征以及药效学。

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.