NCT00211198已完成4 期
Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
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
- 60
- 试验地点
- 17
- 主要终点
- To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
研究概览
简要总结
The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.
The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.
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
- •Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
- •Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
- •Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN).
- •Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN.
- •Albumin >3.0 g/dL
- •Adequate renal function as indicated by SCr < or equal to 2.5 mg/dl.
- •ECOG performance status between 0-
- •Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
- •Patients over the age of 18 who are willing and able to provide Informed Consent.
排除标准
- •Pathology consistent with peripheral T-cell lymphoma.
- •Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
- •History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
- •Patients who are pregnant or breast feeding.
- •Allergy to or have history of allergy to diphtheria toxin or IL-
- •Previous ONTAK® usage.
- •Unstable cardiovascular disease.
- •Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
- •Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
结局指标
主要结局
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
次要结局
- Physician's Global Assessment (PGA)
- Time to Event Variables - Time to response, remission, treatment failure
- Response based on the CD25 status
- Response based on patient demographics: stage of disease, age, sex, performance status, total dose
- Number of cycles completed
- 6. Assess safety and tolerability of ONTAK
研究者
研究点 (17)
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