EUCTR2006-003353-24-IT进行中（未招募）不适用
Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin(bexarotene) and one other Standard Therapy - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GENMAB
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. A biopsy compatible with the diagnosis of MF with a CD4 positive phenotype within 6 months of study entry
- •2. MF stage IB to IVB (highest stage ever)
- •3. Refractory to or intolerant to at least two prior therapies, one being Targretin (or combinations hereof), and the other being the current standard therapy at each institution. Stage 1 patients are only required to be refractory or intolerant to at least one prior current standard therapy
- •4. WHO performance status 0, 1 or 2
- •5. Age >= 18 years
- •6. Following receipt of verbal and written information about the study, the patient must provide signed consent before any study related activity is carried out
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Sezary syndrome
- •2. Primary cutaneous anaplastic large cell lymphoma
- •3. Lymphomatoid papulosis
- •4. Histopathological evidence of sheets of large cells (from skin or nodes) or poorly differentiated tumors
- •5. Prior treatment with combination chemotherapy within six months
- •6. Prior treatment with Total Skin Electron Beam (TSEB) therapy within one year
- •7. Prior treatment with Campath (alemtuzumab)
- •8. Prior treatment with more than three regimens of single agent chemotherapy
- •9. Prior treatment with pentostatin within two years 17. Known or suspected positive serology for HIV
- •18. Known or suspected positive serology for hepatitis B or C
- •19. Signs or symptoms of CNS involvement
- •20. 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)
- •21. Prior treatment with anti-CD4 monoclonal antibodies
- •22. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •23. Breast feeding women or women with a positive pregnancy test at Visit 1
- •24. Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
研究者
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