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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02392780

Enrollment

Registered

2015-03-19

Start date

2015-04-30

Completion date

Unknown

Last updated

2015-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-graft-versus-host Disease

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.

Interventions

DRUGCannabidiol

Oral cannabidiol at a dose of 150 mg BID up to 90 days.

DRUGMethylprednisolone

IV methylprednisolone 2 mg/kg/day

DRUGCalcineurin 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with complete remission of acute GVHD	90 days

Secondary

Measure	Time frame
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

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactMoshe Yeshurun, MD

moshey@clalit.org.il972-50-4065543

Backup ContactLiat Shargian, MD

LIATSHR@clalit.org.il972-54-2394930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026