NCT00553943已完成2 期
Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
Lymphoma Study Association45 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 45
- 主要终点
- Response to treatment (CR/PR)
研究概览
简要总结
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:
- before cerebral radiotherapy for PCL
- after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosis.
- •Diagnosis proved by histological or cytological examination of cerebral specimens, CSF or vitreous humour.
- •Diffuse large cell CD20+ lymphoma.
- •Men or women between the ages of 18 and 60 years.
- •Presence of a measurable target to evaluate response.
- •Negative serological tests for HIV, hepatitis B (except in cases of vaccination), hepatitis C.
- •Life-expectancy ≥ 3 months
- •Patient having given written consent to participate in this study.
排除标准
- •CD20- lymphoma.
- •History of indolent lymphoma, treated or untreated.
- •Contraindication for one of the products used in polychemotherapy.
- •Known hypersensitivity to mouse antibodies.
- •Absence of measurable target to evaluate response.
- •History of cancer in the 5 years prior to inclusion except for cutaneous basocellular carcinomas and non-invasive carcinomas of the neck of the uterus.
- •Cardiac contraindication to treatment with anthracyclines or to hyperhydration:
- •SEVERE DISTURBANCE OF HEART RHYTHM VENTRICULAR EJECTION FRACTION BELOW 50% HISTORY OF RECENT MYOCARDIAL INFARCTION
- •Previously known severe renal insufficiency and/or creatinaemia >150 µM/L (apart from invasion of the kidneys by the lymphoma).
- •Total bilirubin >30 µmol/L, ASAT, ALAT >2.5 times the upper normal value (apart from invasion of the liver by the lymphoma).
- •Insufficient medullary reserve: PNL < 1 G/L and platelets <100 G/L (apart from invasion of the medulla by the lymphoma).
- •History of organ transplantation or other causes of severe immunosuppression.
- •Pregnant woman.
- •Patient incapable of keeping to regular monitoring.
研究组 & 干预措施
Rituximab + Cytarabine
Experimental
干预措施: Rituximab (Drug)
Rituximab + Cytarabine
Experimental
干预措施: Cytarabine (Drug)
结局指标
主要结局
Response to treatment (CR/PR)
时间窗: End of treatment - 5 months
次要结局
- Toxicity, Overall survival, Time to progression(End of study - 5 years)
研究者
研究点 (45)
Loading locations...
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