NCT00127881终止3 期
Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy
Emergent Product Development Seattle LLC35 个研究点 分布在 5 个国家目标入组 76 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 35
- 主要终点
- PGA Score
研究概览
简要总结
The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
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
- •A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
- •Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
- •Signed informed consent
排除标准
- •Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
- •Prior treatment with Campath (alemtuzumab)
- •Prior treatment with more than three regimens of single agent chemotherapy
- •Prior treatment with pentostatin within 6 months
- •Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
- •Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
- •Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease
- •Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
- •Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
- •Known or suspected positive serology for HIV
- •Known or suspected positive serology for hepatitis B or C
- •Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
- •Prior treatment with anti-CD4 monoclonal antibodies
- •Breast feeding women or women with a positive pregnancy test at Visit 1
- •Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
研究组 & 干预措施
Zanolimumab
Experimental
干预措施: HuMax-CD4 (zanolimumab) (Drug)
结局指标
主要结局
PGA Score
时间窗: Duration of Study
次要结局
未报告次要终点
研究者
研究点 (35)
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