Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete resolution of acute GVHD
研究概览
简要总结
Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.
The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.
As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.
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 over 18 years
- •Acute GVHD grade I/II
- •No history of psychosis
- •Signed informed concent
排除标准
- •Acute GVHD grade > II
- •History of psychosis
- •History of asthma
研究组 & 干预措施
Oral Cannabidiol
Patients undergoing allogeneic SCT will receive standard GVHD prophylaxis consisting of a calcineurin inhibitor and methotrexate or mycophenolate mofetil. Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Complete resolution of acute GVHD
时间窗: within 90 days from start of therapy
次要结局
- Percentage of patients developing chronic GVHD(12 months)
- percentage of patients developing > or = grade 3 toxicity(6 months)