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

Sponsor

moshe yeshurun (Other)

Overall Status

Unknown status

CT.gov ID

NCT02392780

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute-graft-versus-host Disease	Drug: Cannabidiol Drug: Methylprednisolone Drug: Calcineurin inhibitor	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabidiol	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)

Arm

Intervention/Treatment

Experimental: Cannabidiol

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)

Outcome Measures

Primary Outcome Measures

Proportion of patients with complete remission of acute GVHD [90 days]

Secondary Outcome Measures

Proportion of patients with partial remission of acute GVHD [90 days]
Proportion of patients with chronic GVHD [12 months]
Proportion of patients able to discontinue immunosuppression [12 months]
Transplant related mortality [12 months]

Other Outcome Measures

Subpopulations of peripheral blood cells and cytokine levels [12 months]
T4, T8, Foxp3 T regulatory cells, TNFα, INFγ, IL-1β, IL-6, IL-17, IL-4, IL-5, IL-10 and IL-13