Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Graft Versus Host Disease Clinical Trial

Official title:

Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01385124
• Other study ID #: 6276
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 28, 2011
• Last updated: June 18, 2015
• Start date: September 2012

Study information

• Verified date: September 2012
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 972-9378127
• Email: moshey[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed.

The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects.

As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing allogeneic stem cell transplantation.

2. No previous history of psychosis. -

Exclusion Criteria:

1. Previous history of psychosis.

2. Consumption of cannabis during the last 2 moths before transplantation. -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Oral Cannabidiol
Cannabidiol will be dissolved in oil to a predefined concentration. Patients will be given oral cannabidiol 10 mg twice daily from conditioning starting day and until day +30 after allogeneic transplantation.

Locations

Country	Name	City	State
Israel	Davidoff Cancer Center, Beilin hospital, Rabin medical center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall percentage of patients with acute GVHD at day 100 post-transplant		day 100	Yes
Secondary	Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant		day 100	Yes