Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 主要终点
- Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100
研究概览
简要总结
Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.
The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute leukemia in complete remission
- •Myeloablative conditioning
- •Matched or one antigen or allele mismatched sibling or unrelated donor
排除标准
- •History of psychosis
- •Bronchial asthma
研究组 & 干预措施
Cannabidiol arm
Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.
干预措施: Cannabidiol (Drug)
Cannabidiol arm
Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.
干预措施: cyclosporine (Drug)
Cannabidiol arm
Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100
时间窗: 100 days
grade 3-4 adverse effects attributed to CBD consumption
时间窗: 180 days
Incidence of late onset acute GVHD
时间窗: 12 months
Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months
时间窗: 12 months
次要结局
- Overall survival(12 months)
- Disease free and immunosuppression free survival by 12 months(12 months)
- Non relapse mortality(12 months)
- Relapse rate(12 months)
- Adherence to study protocol(Until day 100)