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临床试验/EUCTR2009-012143-42-IT
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

发起方
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS

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