An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Hepatic response
研究概览
简要总结
Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial infusion of methylprednisolone.
详细描述
The study population will include 30 patients with SR AGVHD having an index of B, C, or D on the IBMTR severity index localized to the liver.
Standard treatment for SR AGVHD includes: IV cyclosporine or tacrolimus with adjusted doses depending on serum levels and methylprednisolone or prednisone 2 mg/kg/d. This treatment may be continued during the study period although steroid taper down should be attempted if clinically possible.
GVHD diagnosis will be based upon clinical criteria and biopsy (if needed) from an involved organ. GVHD will be graded according to the International Bone Marrow Transplantation Registry (IBMTR) severity index.
Intra-arterial treatment should be given in less than 72h from completion of inclusion criteria.
Partially responding or non-responding patients may receive a second treatment within 14 days of the initial intra-arterial treatment, at the discretion of the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of allogeneic stem cell transplantation.
- •Age>18 years.
- •Post stem cells transplant <100 days.
- •AGVHD of liver, IBMTR index B, C, D.
- •Resistant AGVHD - Patients will be eligible for inclusion if they developed grade B-D AGVHD with progression after 3 days standard treatment OR unresponsive to at least 7 days standard treatment OR incomplete response to standard treatment after 14 days.
- •Has received no 1st line treatment for steroid refractory AGVHD.
- •Signed a written informed consent
排除标准
- •Not fulfilling any of the inclusion criteria.
- •Active life-threatening infection.
- •Inability to comply with study requirements.
- •Inability to give informed consent.
- •Contraindication to arterial catheterization (uncorrectable coagulopathy, severe allergic reaction to contrast material or others).
- •Inability to give the first Intra-arterial treatment in less than 72h from completion of inclusion criteria
- •An IBMTR index ≤ A.
- •Refractory skin AGVHD or severe diarrhea..
- •Pregnant or breast-feeding female or childbearing potential.
- •Known to be HIV positive.
- •Has been diagnosed with veno-occlusive disease.
- •Has been diagnosed with multi organ failure.
- •Known renal failure eGFR <30
研究组 & 干预措施
treatment
干预措施: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids) (Drug)
结局指标
主要结局
Hepatic response
时间窗: 180 days
The degree to which serum bilirubin levels do or do not decrease
次要结局
未报告次要终点