EUCTR2014-004267-20-DE进行中（未招募）1 期
Multicenter, randomized Phase 2 Trial to determine the Response Rate of Ruxolitinib and Best Available Treatment (BAT) versus BAT in Steroid-refractory acute Graft-versus-Host Disease (aGvHD) - RIG
Medical Center - University of Freiburg0 个研究点目标入组 0 人开始时间: 2015年3月18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
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.Acute skin, intestinal (histologically confirmed) or liver GvHD > grade 1 according to standard criteria
- •2.Age >=18 years
- •3.Failure of previous treatment, defined as presence of at least one of the following criteria:
- •3a.Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment
- •3b.Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment
- •3c.Failure to taper the prednisone/prednisolone to 0.6 mg/kg/day or methylprednisolone dose to <0.5 mg/kg/day
- •4.Written informed consent
- •5.Ability to understand the nature of the study and the study related procedures and to comply with them
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Uncontrolled underlying disease
- •2.Active bleeding
- •3.Absence of clinical signs of acute GvHD
- •4.Diagnostic or distinctive clinical signs of chronic GvHD
- •5.Uncontrolled bacterial, viral or fungal infection
- •6.Absolute neutrophil count <0.5 x103/µl
- •7.Evidence of transplant-associated microangiopathy (TAM)
- •8.Any previous JAK2 inhibitor treatment prior to study enrolment, except Ruxolitinib given prior to the allogeneic stem cell transplantation
- •9.Known Hypersensitivity to Ruxolitinib or any of the excipients
- •10.Known positivity for HIV, Hepatitis B or Hepatitis C at the time of screening.
- •11.Female patients who are pregnant or breast feeding
- •12.Concomitant use of any other investigational drug within the last thirty days before the start of this study
研究者
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