NCT00849355Unknown2 期
Phase II, Multicenter Trial to Evaluate the Efficacy and Safety of the Following Treatment Squeme:Ciclophosphamide, Vincristine, Lyposomal Doxorrubicine, Myocet and Prednisone,Combined With Rituximab in First Line Treatment for Patients With Aggresive No Hodgkin B Lymphoma and Cardiovascular Risk
Asociacion Doctor Peset Para el Estudio de la Hematología12 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 12
- 主要终点
- Evaluate treatment efficacy by measuring response to treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:Ciclophosphamide, Vincristine, lyposomal Doxorrubicine (Myocet) and Prednisone,combined with Rituximab in first line treatment for patients with aggresive No Hodgkin B lymphoma and cardiovascular risk
详细描述
Phase II, multicenter, open , 1-arm study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological diagnosis of Lymphoma no Hodgkin B CD20+ high degree of mailgnancy
- •Patients no previously treated
- •stage III o IV
- •Informed consent
- •At least one measurable injury
- •Life expectancy >6 months
- •Cardiovascular risk defined as:Mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension
- •adequate organic functionallity (creatinine<2mg/dl;bilirubin<2mg/dl; ALT-AST-FA<5 FSN; neutrphyls total count >1.5x 109/l and platellet count >100x1097l)
- •Use of a contraceptive method during study + 3 months -
排除标准
- •stage I or II with IPI=0
- •Symptomatic tumoral affection of Nervous central system
- •Lymphoma no hodgkin B indolent
- •Lymphoma no hodgkin B mantle-cell
- •Lymphoma no hodgkin T
- •lymphoprolifertaive syndrome post-transplantation or immunosuppression associated
- •cardiovacualr disease symptomatic
- •Cronic infection or acute serious
- •history of neoplasia in past 5 years
- •not able to understand the study or poor protocol adherence
- •Known Hypersensivity to any atudy drug
- •pregnant/lactant women
- •Previous participation in clinicla study in past 30 days
- •Previous treatment with antraciclines or any drug used in this study
研究组 & 干预措施
unique
Experimental
RCOMP-14 with Rituximab
干预措施: RCOMP-14 + rituximab (Drug)
结局指标
主要结局
Evaluate treatment efficacy by measuring response to treatment
时间窗: at the end of study
次要结局
- evaluate cardiotoxicity and tolerability(At the end of study)
- Evaluate progression free survival(At the end of study)
- Evaluate event free survival(At the end of study)
- Evaluate tumor free survival(At the end of study)
- Evaluate overall survival(At the end of study)
- Evaluate response duration(At the end of study)
- treatment adherence(At the end of study)
- time to progression(At the end of the study)
- dose intensity and relative dose intensity(At the end of the study)
研究者
研究点 (12)
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