drugset / Trial / NCT01596075

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

NCT01596075

Phase 1/2 Unknown 40 enrolled Rabin Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed. The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects. As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.

Timeline

Start
2012-07
Primary completion
2015-07
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 600 mg Oral