NCT00050999已完成4 期
A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to 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
- 195
- 试验地点
- 62
- 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 compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
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
- Double
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
- •Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
- •Patient must have had 1 to 3 prior CTCL 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 regimen is permitted. Topical or systemic steroids are not considered a therapy;
- •Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
- •Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
- •Measurable or evaluable disease. Lymph node involvement no greater than LN
- •No CTCL involvement of bone marrow.
- •No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
- •No systemic infections;
- •Willingness to be randomized to a placebo treatment only arm;
- •ECOG performance status 0 or 1;
排除标准
- •Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
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 (62)
Loading locations...
相似试验
已完成
2 期
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, ChronicNCT00055146Eisai Inc.41
已完成
2 期
A Study of ONTAK in Patients With Relapsed or Refractory, B-Cell Non Hodgkin's LymphomaLymphoma, B-CellNCT00211276Eisai Inc.50
已完成
2 期
Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)Non-Hodgkin's LymphomaLymphoma, B-cellLymphoma, Low-gradeNCT00051025Eisai Inc.9
已完成
2 期
Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.Grade I or II Essential HypertensionNCT02072330Takeda353
进行中（未招募）
2 期
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)Chronic Hepatitis B Virus InfectionHepatitis BNCT06537414GlaxoSmithKline283