DRKS00000582已完成2 期
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma (PRIMAIN) - PRIMAIN-Studie
niversitätsklinikum Freiburg- vertreten durch:Leitenden Ärztlichen Direktor0 个研究点目标入组 112 人开始时间: 2010年10月29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
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 one（—）
- 性别
- All
入选标准
- •first diagnosis of PCNSL, histologically confirmed
- •-age > 65 years
- •-written signed and dated informed consent of the legal representative and - if possible - of the patient
排除标准
- •* manifestations of further lymphoma outside the CNS
- •* sero-positive for HIV
- •* severe pulmonary, cardiac, hepatic, renal impairment
- •* uncontrolled infection
- •* neutrophil count < 1.500/µl, platelet count < 100.000/µl
- •* pulmonary disease with IVC < 55%, DLCO < 40%
- •* cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
- •* creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- •* bilirubin > 2mg/dl
- •* ascites or pleural effusion (> 500ml)
- •* known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
- •* 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
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