CTRI/2012/04/002587进行中（未招募）3 期
A randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone vs. MabThera® plus cyclophosphamide, vincristine, prednisone, followed by GP2013 or MabThera® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Hexal AG
- 入组人数
- 618
- 试验地点
- 34
- 主要终点
- Overall response rate in patients with Follicular Lymphoma
研究概览
简要总结
The purpose of this clinical study is to demonstrate comparability between the biosimilar agent GP2013 and MabThera® (which in some countries also marketed under the name Rituxan®)
Note: The inadvertant/system error in tab "Recruitment Status of Trial" led to change in enrollment status on 24 Jan 2013. The error was corrected on 15 Feb 2013. The recruitment status is "Open to Recruitment".
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •Patient with previously untreated advanced stage, CD20-positive FL
- •Patient with ECOG performance status 0, 1 or
- •Other protocol-defined inclusion criteria will apply.
排除标准
- •Key Exclusion Criteria:
- •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 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 exclusion criteria will apply.
结局指标
主要结局
Overall response rate in patients with Follicular Lymphoma
时间窗: Time Frame - 24 weeks
次要结局
- Percentage of patients with Adverse Events (AEs)(Time Frame - upto 2 years)
研究者
研究点 (34)
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