NCT01419665已完成3 期
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 629
- 试验地点
- 153
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with previously untreated advanced stage, CD20-positive FL
- •Patient with ECOG performance status 0, 1 or 2.
排除标准
- •Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
- •Patient who has previously received any prior therapy for lymphoma
- •Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
- •Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 24 weeks
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
次要结局
- To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization(3 years)
- To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period(24 weeks)
- To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period(24 weeks)
- To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)(24 weeks, 3 years)
- To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)(day 63)
- To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)(day 63)
- To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy(21 days)
- To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths(3 years)
研究者
研究点 (153)
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