EUCTR2009-012143-42-IT进行中(未招募)1 期
Multicenter study of phase II with Rituximab, cyclophosphamide, doxorubicin liposomal (Myocet), vincristine, Prednisone, (R-COMP) in diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient - HEART01
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS0 个研究点目标入组 50 人开始时间: 2009年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
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
- •1. NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; 2.Age >= 18 years; 3.Presence of at least 1 factor that defines the cardiopathy(see Annex F); 4.Life expectancy > 3 months; 5.In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; 6.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Histology different from NHL diffuse large cell CD20 + or follicular IIIb 2.Age < 18 years 3.Inability to sign informed consent; 4.HIV positivity; 5.Patients HBsAg positive; 6.AST / ALT > 2 times the standard; 7.Bilirubin > 2 times the standard; 8.Creatinina > 2.5 mg / dl; 9.Location of CNS disease; 10.Pregnancy ongoing; 11.Damage to that organ or medical problems that could interfere with the therapy; 12.Current uncontrolled infection; 13.Senile dementia
研究者
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