NCT00989352Unknown2 期
Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
University Hospital Freiburg2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2009年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Complete remission rate
研究概览
简要总结
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
结局指标
主要结局
Complete remission rate
时间窗: 30 days after end of immuno-chemotherapy
次要结局
- Duration of response(within 5 years)
- Overall survival time(within 5 years)
- Neuropsychological state (according to Mini-Mental State and IPCG testing)(within 5 years)
- (Serious) adverse events ([S]AEs)(within 30 days after treatment)
研究者
研究点 (2)
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