跳至主要内容
临床试验/EUCTR2006-004772-12-DK
EUCTR2006-004772-12-DK进行中(未招募)1 期

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: 2006年11月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
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

  • Inclusion criteria
  • Pathologically verified primary central nervous system lymphoma
  • No prior PCNSL treatment. Patients treated with steroids alone are eligible
  • No signs of lymhpoma outside the CNS
  • ECOG performance status 0-4 (Appendix 1)
  • Age > 18 and < 75 years
  • Written informed consent from the patient or guardian
  • 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

  • Exclusion Criteria
  • Cardiac failure > 3 (NYHA , Appendix 2)
  • Pregnancy or lactation
  • Previous malignancy unless diseasefree for at least five years
  • Active infection
  • Positive HIV status
  • Organ transplantation
  • Serious psychiatric illness
  • Prior radiotherapy to the brain
  • 5.2.9 Concomitant anti-inflammatory medication that cannot be discontinued
  • 5.2.10 Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
  • (Appendix 4)
  • 5.2.11 Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
  • 5.2.12 Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits
  • 5.2.13Known 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

发起方
ordic Lymphoma Group

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