EUCTR2007-007847-28-DE进行中（未招募）1 期
A multicenter, randomized, two-armed, open-label Phase III study to evaluate the adjuvant vaccination with tumor RNA-loaded autologous Dendritic Cells versus observation of patients with resected monosomy 3 uveal melanoma - Uveal melanoma / Dendritic Cells + autologous tumor RNA
niversitätsklinikum Erlangen0 个研究点目标入组 200 人开始时间: 2010年11月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •Resected uveal melanoma displaying monosomy 3, no evidence for metastases, WHO performance status of 0, 1 or 2, age over 18 years, negative pregnancy test, signed informed consent
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Evidence for metastases, seriously impaired haematological, hepatic or renal function, major serious illness, evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection, autoimmune diseases, splenectomy or radiation therapy of the spleen, organ allografts, simultaneous chemo- or radiation therapy, simultaneous immunotherapy, pregnancy, lactation, psychiatric disorders, organic brain syndrome
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