EUCTR2005-000615-99-DE进行中（未招募）不适用
Freiburger ZNS-NHL StudieTherapie für Patienten mit primären Non-Hodgkin Lymphomen des ZNS – Sequentielle Hochdosis-Chemotherapie mit autologer peripherer Blutstammzelltransplantation - Freiburger ZNS-NHL-Studie
niversity Medical Center Freiburg0 个研究点开始时间: 2006年10月13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
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
- •- group A: first diagnosis of PCNSL, histolgically confirmed
- •- group B: relapse or progression of PCNSL after MTX containing chemotherapy
- •- age 18 - 65 years
- •- not legally incompetent, physically or mentally incapable of giving consent
- •- written signed and dated informed consent of the legal representative and - if possible - of the patient
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- manifestations of further lymphoma outside the CNS
- •- sero-positive for HIV
- •- severe pulmonary, cardial, hepatic, renal impaiment
- •- neutrophile count < 2.000/µl, platelet count < 100.000/µl
- •- pulmonary disease with IVC < 55%, DLCO < 40%
- •- kardiac ejection fraction < 50%, uncontrolled maligne arrhythmia
- •- creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- •- bilirubin > 2mg/dl
- •- ascites or pleural effusion (> 500ml)
- •- pregnancy o r lactation
- •- women with childbearing potential without sufficient contraception
- •- participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
- •- known or current drug or alcohol abuse
- •- known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorine, dexamethasone, neupogen and neulasta.
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