跳至主要内容
临床试验/EUCTR2012-004118-33-IT
EUCTR2012-004118-33-IT进行中(未招募)不适用

High-dose cyclophosphamide role in the prophylaxis of GVHD in elderly patients (66-70 years) with acute leukemia or myelodysplasia high-risk, submitted to allogenic transplant of peripheral hematopoietic progenitor cells after reduced-intensity conditioning. - transplant over66

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2012年12月19日最近更新:
适应症
相关药物

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

  • LAM high risk [intermediate or poor risk cytogenetics - normal karyotype with unfavorable molecular alterations - failure of the 1st cycle of induction - secondary leukemia - second complete remission] in complete remission High-risk MDS (IPSS = intermediate II) ALL in complete remission Age> 66 years and <71 Availability of an HLA-matched donor hematopoietic progenitors Written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • 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 20

排除标准

  • Age> 70 years Psychiatric disorders or other conditions that compromise adequate compliance to the therapeutic program Karnofsky score <60% EF <40% Renal disease (creatinine clearance <40 ml / min) Severe liver disease (ALT> 2.5 vv normal value) or acute hepatitis Deficits in lung function (FEV1, FVC, DLCO <50% of the expected after correction for hemoglobin) HIV (Human Immunodeficiency Virus) HIV Obesity morbigena, or third-degree Infections in the active phase A history of cancer of other organs and tissues not in remission or at high risk of recurrence if prolonged immunosuppressive therapy.

研究者

发起方
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)

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