ISRCTN74547745已完成3 期
Randomized Phase III trial: Maintenance therapy with the monoclonal chimeric antibody rituximab compared to observation in patients with CD20+ B-cell Non-Hodgkins lymphoma
niversity of Heidelberg (Germany) and Roche (Switzerland)0 个研究点目标入组 174 人开始时间: 2005年12月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. B-cell CD20+ Non-Hodgkins Lymphoma (primary therapy and relapse). At study entry patients with agressive lymphoma need to have a complete remission, if a residual tumor is still present a positron-emission-tomography examination needs to reveal no active tumor. Patients with indolent lymphoma need at least a partial remission to enter this trial
- •2. Age above 18 years
- •3. Karnofsky Index above 60
- •4. Contraception and negative pregnancy test of women in reproducitve age
- •5. Valid patient approval
排除标准
- •1. Manifest cardiac insufficiency
- •2. Chronic obstructive lung disease with hypoximia
- •3. Uncontrolled hypertension
- •4. Renal insufficiency (creatinine above 2 mg/dl)
- •5. Hepatic insufficiency (Bilirubin above 2.0 mg/dl)
- •6. Pregnancy
- •7. Breast feeding
- •8. Severe psychiatric illness
- •9. Human immunodeficiency virus (HIV) positive patients
- •10. Primary cerebral lymphoma
- •11. Previous allogeneic transplant
研究者
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