NCT03701698终止2 期
Ruxolitinib and Methylprednisolone As First Line Therapy for Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD).
详细描述
Treatment:
Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.
- Methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. Taper steroid every one or two weeks according to patient's response.
- Ruxolitinib 5~10mg bid po for at least 28 days. If patient's ANC<0.5×10e9/L or PLT< 20×10e9/L, cease ruxolitinib until recovery of ANC higher than 0.5×10e9/L or PLT higher than 20×10e9/L.
Indication for stopping Ruxolitinib treatment:
- No response after ruxolitinib treatment for 28 days.
- Develop life-threatening complication.
- ANC<0.5×10e9/L or PLT< 20×10e9/L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with hematological diseases.
- •recipients of allogeneic peripheral blood stem cell transplantation.
- •new onset of grade II~IV acute graft versus host disease within 100 days post-transplantation.
- •exclusion criteria:
- •recipients of second allogeneic stem cell transplant.
- •acute GVHD induced by donor lymphocyte infusion, interferon.
- •received treatment other than steroid before enrollment.
- •overlap GVHD syndrome.
- •pregnant or breast-feeding women.
- •absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- •non-GVHD related liver dysfunction: glutamic pyruvic transaminase>= 4 times of upper normal limit, direct bilirubin >= 4 times of upper normal limit
- •renal dysfunction: creatinine clearance < 15 mL/min or glomerular filtration rate< 15 mL/min
- •uncontrolled infection
- •human immunodeficiency virus infection
- •active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
- •relapse of primary malignant hematological diseases, or graft rejection.
- •allergic history to Janus kinase inhibitors.
排除标准
- 未提供
研究组 & 干预措施
combination therapy
Experimental
There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone.
- Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.
- Ruxolitinib oral tablet, 5~10mg bid orally, for at least 28 days.
干预措施: Ruxolitinib Oral Tablet (Drug)
combination therapy
Experimental
There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone.
- Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.
- Ruxolitinib oral tablet, 5~10mg bid orally, for at least 28 days.
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
overall response rate
时间窗: 28 days after treatment
overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy.
次要结局
- 1 year incidence of chronic GVHD(1 year within transplant)
- reactivation rate of cytomegalovirus(100 days within transplant)
- time to response(28 days after treatment)
研究者
Xianmin Song, MD
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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