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
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
- 否
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
研究点 (2)
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