Graft vs Host Disease Clinical Trial
Official title:
Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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