EUCTR2017-004385-94-AT进行中（未招募）1 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 follicular lymphoma - Efficacy and safety of tisagenlecleucel in adults with refractory or relapsed follicular lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 113
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent prior to any screening procedures
- •=18 years of age at the time of ICF signature
- •FL (Grade 1, 2, 3A) confirmed histologically by central pathology review before tisagenlecleucel infusion.
- •FL meeting one of the following criteria:
- •oRefractory to a second line or later line of systemic therapy (including anti-CD20 antibodies and alkylating agents) or relapsed within 6 months after completion of a second line or later line of systemic therapy
- •oRelapsed during anti-CD20 antibody maintenance (following at least two lines of therapies as above) or within 6 months after maintenance completion
- •oRelapsed after autologous HSCT
- •Radiographically measurable disease at screening defined as:
- •At least one nodal lesion greater than 20 mm in the long axis, regardless of the length of the short axis AND/OR
- •Extranodal lesions (outside lymph node or nodal mass, including liver and spleen) greater than 10 mm in long AND short axis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
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
研究者
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