Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients with complete remission of acute GVHD
研究概览
简要总结
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.
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
- •Patients 18 years or older
- •After allogeneic transplantation
- •Grade III or IV acute GVHD
- •No psychiatric contra-indication
- •Informed consent
排除标准
- •History of psychosis
- •Known allergy to cannabis constituents
研究组 & 干预措施
Cannabidiol
干预措施: Cannabidiol (Drug)
Cannabidiol
干预措施: Methylprednisolone (Drug)
Cannabidiol
干预措施: Calcineurin inhibitor (Drug)
结局指标
主要结局
Proportion of patients with complete remission of acute GVHD
时间窗: 90 days
次要结局
- Transplant related mortality(12 months)
- Proportion of patients with partial remission of acute GVHD(90 days)
- Proportion of patients able to discontinue immunosuppression(12 months)
- Proportion of patients with chronic GVHD(12 months)
研究者
moshe yeshurun
Head, BMT unit, Rabin Medical Center
Rabin Medical Center