NCT00051012已完成4 期
A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 86
- 试验地点
- 60
- 主要终点
- Objective Rate of Response (ORR), defined as CR + CCR + PR
研究概览
简要总结
The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
- •CTCL disease Stage Ia - III.
- •History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
- •Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN
- •No CTCL involvement of bone marrow.
- •No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
- •No systemic infections.
- •ECOG performance status of 0 or 1.
排除标准
- •The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
结局指标
主要结局
Objective Rate of Response (ORR), defined as CR + CCR + PR
次要结局
- Time-to-Treatment Failure
- Time-to-Progression
- Duration of Response
研究者
研究点 (60)
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