EUCTR2011-004730-34-IT进行中（未招募）不适用
A phase II multicentre, randomized, controlled open-label study on the use of anti-thymocyte globulin and rituximab for immunomodulation of graft-versus-host disease in allogeneic matched transplants for non malignancies - T&Bnm
OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA0 个研究点开始时间: 2012年3月2日最近更新:
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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
- •?Availability of a matched related donor (MRD) or Matched Unrelated Donor (MUD)
- •?Lansky or Karnofsky Index = 60
- •?Inherited metabolic disorders: DQ =70 (+ MRI Loes score = 9 for adrenoleukodystrophy)
- •?Adequate cardiac, renal, hepatic and pulmonary functions as evidenced by:
- •?Serum creatinine =1.5 × upper limit of normal (ULN)
- •?Heart shortening fraction (left-ventricle) > 28 % or LVEF > 55%
- •?Serum bilirubin =1.5 × ULN (except for Wolman disease),
- •?AST and ALT = 2.5 × ULN (except for thalassemic syndromes and Wolman disease)
- •?Pulmonary function: if cooperative: FEV1 and FVC on pulmonary function testing > 60 %; if non cooperative: pulse oximetry > 95 % in room air
- •?Availability of autologous back up marrow (> 2 x 108 TNC+ cells/kg or > 2 x 106 CD34+ cells/kg) for MUD
- •?Adequate contraception in female patients of child-bearing potential
- •?Signed informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?Any malignancy
- •?Liver cirrhosis evidenced on liver histology (performed in suspicious cases or in case of Wolman disease)
- •?HIV- positivity
- •?Clinically significant pleural effusion or ascites
- •?Pregnancy or lactation
- •?Known hypersensitivity to trial drugs
- •?Participation in another experimental drug trial in the 2 months preceding enrolment
- •?Non-cooperative behaviour or non-compliance
- •?Previous HSCT
研究者
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