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临床试验/NCT00093314
NCT00093314撤回1 期

An Open-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

GlaxoSmithKline2 个研究点 分布在 1 个国家开始时间: 2004年10月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
撤回
试验地点
2

研究概览

简要总结

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Chronic Lymphocytic Leukemia
  • Circulating lymphocytes above a specific level
  • Circulating lymphocytes showing certain markers

排除标准

  • Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
  • Previous stem cell transplantation.
  • Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.
  • HIV positivity.
  • Hepatitis B or hepatitis C.
  • Other cancerous diseases, except certain skin cancers and cervix cancer.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
  • Participation in another trial with a different new drug 4 weeks prior to enrollment in study.
  • Current participation in any other clinical study.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use adequate contraception.

研究者

申办方类型
Industry

研究点 (2)

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