A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Eisai Inc.
- 主要终点
- To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphoma
研究概览
简要总结
The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
E7777 + CHOP Chemotherapy
干预措施: E7777 (Drug)
CHOP alone
干预措施: E7777 (Drug)
结局指标
主要结局
To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphoma
时间窗: pre-randomization 4 weeks until disease progression
* Pretreatment or pre-randomization (screening and baseline): 4 weeks. * Treatment: 18 weeks. * Follow up: 2 to 3 years after the end of study treatment. Treatment will stop upon disease progression, unacceptable toxicity, or death, whichever occurs first. The Investigator or subject may also stop study treatment at any time for safety or personal reasons; however subject should remain on study, if possible, for follow-up.
次要结局
- To evaluate whether E7777 in combination with CHOP treatment has superior efficacy compared with CHOP treatment alone as assessed by overall survival (OS) and by transplant rate.· To compare safety of E7777 in combination with CHOP(pre-randomization 4 weeks until disease progression)