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临床试验/EUCTR2004-004741-17-DK
EUCTR2004-004741-17-DK进行中(未招募)不适用

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

Santaris Pharma0 个研究点目标入组 42 人开始时间: 2005年3月17日最近更新:

试验速览

阶段
不适用
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 109/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 according to Intl. Protocol Amendment 2, dated 25 January 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

  • 1)Previous treatment with rituximab within 6 months prior to Visit 1
  • 2)Previous treatment with alemtuzumab within 6 months prior to Visit 1
  • 3)Previous autologous stem cell transplantation within 6 months prior to Visit 1
  • 4)Previous allogeneic stem cell transplantation
  • 5)Received any of the following treatments within 4 weeks prior to Visit 1:
  • Anti-cancer therapy
  • Glucocorticoids unless = 10 mg prednisolon /day for other indications than CLL
  • Radiotherapy
  • 6)Known or suspected transformation of CLL (e.g. B-symptoms, fast growing tumour or increasing LDH level)

研究者

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