跳至主要内容
临床试验/EUCTR2007-000049-36-IT
EUCTR2007-000049-36-IT进行中(未招募)不适用

Phase II study of the histone-deacetylase inhibitor ITF2357 in very high-risk relapsed/refractory Hodgkin's lymphoma patients - ND

ITALFARMACO0 个研究点开始时间: 2007年6月14日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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) Age>=18yrs; 2) history of histologically confirmed Hodgking's Lymphoma 3) subjects are eligible for the trial if they have failed at least 1 cycle of chemotherapy with or without radiotherapy and if they are considered incurable and would be treated with second line or subsequent line salvage regimens mainly with palliative intent; 4)ANC >=1500/uL; PLT >=75000/uL; Hb >=9g/dL; bilirubin <=1.6 mg/dL; AST and ALT <=2.5 x UNL, creatinine <=2.0 mg/dL, K and Mg within normal limits; 5) measurable disease 6) ECOG performance status of 0 or 1
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • 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) Acitive bacterial or mycotic infection 2) a marked baseline prolongation of QTc interval > 450 msec 3) the use of concomitant medications that prolong the QTc interval 4) clinically significant cardiovascular disease 5) positive blood test for HIV, HBV and HCV 6) Identification of viral DNA by PCR for EBV, JC Virus, CMV and Herpes Zoster

研究者

发起方
ITALFARMACO

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