NCT00092274撤回1 期
An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
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 Follicular Lymphoma (FL).
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
- •Relapsed or refractory follicular lymphoma grade I-II
- •Tumor verified to be CD20 positive
- •CT scan showing demarcated lesions
排除标准
- •Previous treatment with rituximab resulting in less than partial response
- •Previous radioimmunotherapy
- •Previous stem cell transplantation
- •Received the following treatments within 4 weeks prior to entering this study:
- •Anti-cancer therapy
- •Glucocorticosteroids unless less than 10 mg prednisolone/day
- •Radiotherapy
- •Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
- •HIV positivity
- •Hepatitis B or hepatitis C
- •Uncontrolled or chronic bacterial, fungal or viral infection
- •Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
- •Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
- •WHO performance status of 3 or 4
- •If you are participating in another trial with a different new drug 4 weeks before you enter this trial
- •Current participation in any other clinical study
- •Pregnant or breast-feeding women
- •Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
研究者
研究点 (2)
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