NCT02392780

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: moshe yeshurun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute-graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	Cannabidiol	Oral cannabidiol at a dose of 150 mg BID up to 90 days.
DRUG	Methylprednisolone	IV methylprednisolone 2 mg/kg/day
DRUG	Calcineurin inhibitor	cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-04-01
• First posted: 2015-03-19
• Last updated: 2015-03-19

Locations

1 site across 1 country: Israel