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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
10
Patients will receive standard GVHD prophylaxis consisting of cyclosporine A twice daily starting on day -1 with target trough levels of 200-400 ng/mL and a short course of methotrexate (15 mg/ m2 on day 1 and 10 mg/ m2 on days days 3 and 6). Patients transplanted from unrelated donors will receive ATG Fresenius at a low dose of 5 mg/kg on days -3 to -1. Patients will be given oral CBD 150 mg BID starting 7 days before transplantation until day 100.
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
Non relapse mortality
Time frame: 12 months
Relapse rate
Time frame: 12 months
Overall survival
Time frame: 12 months
Adherence to study protocol
Percentage of doses actually taken as reported by patients
Time frame: Until day 100
Disease free and immunosuppression free survival by 12 months
Time frame: 12 months
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