Clinical Trial: Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
Brief Summary:
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.
Detailed Summary:
Sponsor: Rabin Medical Center
Current Primary Outcome:
- Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100 [ Time Frame: 100 days ]
- grade 3-4 adverse effects attributed to CBD consumption [ Time Frame: 180 days ]
- Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months [ Time Frame: 12 months ]
- Incidence of late onset acute GVHD [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Non relapse mortality [ Time Frame: 12 months ]
- Relapse rate [ Time Frame: 12 months ]
- Overall survival [ Time Frame: 12 months ]
- Adherence to study protocol [ Time Frame: Until day 100 ]Percentage of doses actually taken as reported by patients
- Disease free and immunosuppression free survival by 12 months [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: June 15, 2015
Date Started: July 2015
Date Completion: June 2017
Last Updated: June 22, 2015
Last Verified: June 2015