ISRCTN87866680已完成2 期
Primary treatment with high-dose therapy and purged/unpurged autologous stem cell transplantation (ASCT), including rituximab for induction and in-vivo purging and maintenance
Individual sponsor (Denmark)0 个研究点目标入组 50 人开始时间: 2008年2月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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. Newly diagnosed patients fulfilling the diagnostic criteria of mantle cell lymphoma
- •2. Ann Arbor stage II - IV
- •3. 18 - 65 years of age, either sex
- •4. Have given informed consent
排除标准
- •Any organ dysfunction or failure that may present a risk to the patient during any phase of protocol treatment:
- •1. Renal function decreased corresponding to P-creatinine and/or blood urea nitrogen (BUN) increased to 2 x upper normal limit, unless clearly explained by the lymphoma
- •2. Liver biochemistry abnormal (P-Bilirubin, alanine aminotransferase [ALAT] or alkaline phosphatase increased to 2 x upper normal limit) unless clearly explained by the lymphoma
- •3. Chronic infections including human immunodeficiency virus (HIV) and hepatitis B
- •4. Pregnancy or lactation: for women of the childbearing age at inclusion adequate anti-conception must be secured (P-pills, depot injection gestagen or intra-uterine device)
- •5. Other malignancy except skin (non-melanoma) or cervix carcinoma stage 1
研究者
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