EUCTR2011-004039-30-GB进行中（未招募）不适用
Rituximab, High Dose Ara-C and Dexamethasone Followed by BEAM in Mantle Cell Lymphoma Patients <66 Years - MCL5 MARiT Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age <66 years.
- •2.Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation.
- •3.All patients in need of treatment.
- •4.No previous treatment for lymphoma except one cycle of any chemotherapy regimen.
- •5.WHO performance status of 0 – 2.
- •6.Life expectancy of more than 3 months.
- •7.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Severe cardiac disease: NYHA grade 3-4.
- •2.Impaired liver, renal (GFR<50ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment.
- •3.Pregnancy/lactation
- •4.Men or women of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
- •5.Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
- •6.Known seropositivity for HIV, HCV, HBsAg or other active infection uncontrolled by treatment.
- •7.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
研究者
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