Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Response Rate - Cutaneous T Cell Lymphoma (CTCL)
研究概览
简要总结
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells.
PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate of patients with relapsed or refractory cutaneous T-cell non-Hodgkin lymphoma (CTCL) following treatment with RFT5-dgA immunotoxin (anti-CD25 immunotoxin IMTOX25) .
Secondary
- Determine whether responses correlate with the level of CD25+ expression on the CTCL tumor cells.
- Determine whether changes in the pre-treatment and the post-treatment levels of CD4+CD25+ Treg cells correlate with responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 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
IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
干预措施: immunohistochemistry staining method (Other)
IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
干预措施: RFT5-dgA immunotoxin (Biological)
IMTOX25 at 2mg/m²/dose
Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
干预措施: fluorescence activated cell sorting (Other)
结局指标
主要结局
Response Rate - Cutaneous T Cell Lymphoma (CTCL)
时间窗: Once a week for seven weeks
Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
次要结局
未报告次要终点