drugset / Trial / NCT02392780

Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

NCT02392780 ↗

Phase 2 Unknown 10 enrolled moshe yeshurun
NaSingle-groupOpen-labelTreatment

Summary

Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.

Timeline

Start
2015-04
Primary completion
2018-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 150 mg Oral
Background Cyclosporine Peptide — —
Background Methylprednisolone Other / unclassified 2 mg/kg Intravenous
Background Tacrolimus Small molecule — —