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

Acute-graft-versus-host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02392780
• Other study ID #: 0009-15-RMC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 9, 2015
• Last updated: March 18, 2015
• Start date: April 2015

Study information

• Verified date: March 2015
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 972-50-4065543
• Email: moshey[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

Intervention

Drug:
• Cannabidiol
Oral cannabidiol at a dose of 150 mg BID up to 90 days.
• Methylprednisolone
IV methylprednisolone 2 mg/kg/day
• 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)

Locations

Country	Name	City	State
Israel	Davidof Cancer Center, Beilinson hospital, Rabin medical center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
moshe yeshurun

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subpopulations of peripheral blood cells and cytokine levels	T4, T8, Foxp3 T regulatory cells, TNFa, INF?, IL-1ß, IL-6, IL-17, IL-4, IL-5, IL-10 and IL-13	12 months	No
Primary	Proportion of patients with complete remission of acute GVHD		90 days	Yes
Secondary	Proportion of patients with partial remission of acute GVHD		90 days	Yes
Secondary	Proportion of patients with chronic GVHD		12 months	Yes
Secondary	Proportion of patients able to discontinue immunosuppression		12 months	Yes
Secondary	Transplant related mortality		12 months	Yes