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

moshe yeshurun

Status and phase: Unknown; Phase 2

Conditions: Acute-graft-versus-host Disease

Treatments: Drug: Methylprednisolone; Drug: Calcineurin inhibitor; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT02392780

0009-15-RMC

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients 18 years or older
2. After allogeneic transplantation
3. Grade III or IV acute GVHD
4. No psychiatric contra-indication
5. Informed consent

Exclusion criteria

1. History of psychosis
2. Asthma
3. Known allergy to cannabis constituents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cannabidiol

Experimental group

Treatment:

Drug: Calcineurin inhibitor

Drug: Cannabidiol

Drug: Methylprednisolone