jRCT1080224541已完成2 期
A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed (r/r) follicular lymphoma
Novartis Pharma. K.K.1 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Phase II, single-arm, multi-center, open-label study for r/r FL patients
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
- •Radiographically measurable disease at screening
排除标准
- •Evidence of histologic transformation
- •Follicular Lymphoma Grade 3B
- •Prior anti-CD19 therapy
- •Prior gene therapy
- •Prior adoptive T cell therapy
- •Prior allogeneic hematopoietic stem cell transplant
- •Active CNS involvement by malignancy
结局指标
主要结局
-
efficacy CRR (Complete response rate)
次要结局
未报告次要终点
研究者
研究点 (1)
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