EUCTR2006-004772-12-SE进行中（未招募）不适用
Immunochemotherapy in primary central nervous system lymphoma with Rituximab, HD-MTX, HD-Ara C, cyclophosphamide, ifosfamide, vincristine, vindesine, temozolomide and DepoCyte induction followed by maintenance treatment in elderly patients with temozolomide.
ordic Lymphoma Group0 个研究点目标入组 70 人开始时间: 2007年3月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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 Pathologically verified primary central nervous system lymphoma
- •2 No prior PCNSL treatment. Patients treated with steroids alone are eligible
- •3 No signs of lymhpoma outside the CNS
- •4 ECOG performance status 0-4
- •5 Age > 18 and < 75 years
- •6 Written informed consent from the patient or guardi
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 Cardiac failure > 3 (NYHA , Appendix 2)
- •2 Pregnancy or lactation
- •3 Previous malignancy unless diseasefree for at least five years
- •4 Active infection
- •5 Positive HIV status
- •6 Organ transplantation
- •7 Serious psychiatric illness
- •8 Prior radiotherapy to the brain
- •9 Concomitant anti-inflammatory medication that cannot be discontinued
- •10 Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
- •11 Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
- •12 Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper
- •limits of normal.
- •13 Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any
- •component of Rituximab excludes patients from Rituximab treatment, but not
- •from the remaining part of the study
研究者
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