EUCTR2004-004741-17-GB进行中（未招募）1 期
SPC2996 in Chronic Lymphocytic LeukaemiaAn open-labelled, international multicenter dose escalating, phase I/II study of SPC2996, an LNA antisense molecule against Bcl-2, in patients with relapsed or refractory Chronic Lymphocytic Leukaemia - SPC2996 in Chronic Lymphocytic Leukaemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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)Relapsed or refractory CLL/SLLrequiring therapy
- •2)Circulating lymphocytes > 5 x 10E9/L at screening blood sample
- •3)Circulating lymphocytes expressing the following phenotype at screening blood sample: CD5+CD20+CD23+
- •4)(This inclusion criterion has been deleted by Intl. Protocol Amendment 2, dated 25 Jan 2006)
- •5)Age = 18 years
- •6)Following receipt of oral and written information about the study the patient must give a 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
- •The main exclusion criteria are previous treatment with rituximab, alemtuzumab or autologous stem cell transplantation within 6 months prior to Visit 1 or allogeneic stem cell transplantation at any time. Excluded are also patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4 weeks prior to Visit 1 and patients with known or suspected transformation of CLL.
研究者
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