Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Graft Versus Host Disease Clinical Trial

Official title:

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01596075
• Other study ID #: 0388-11-RMC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 9, 2012
• Last updated: September 9, 2012
• Start date: July 2012

Study information

• Verified date: September 2012
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 972-50-4065543
• 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 stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants 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 be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over 18 years

2. Acute GVHD grade I/II

3. No history of psychosis

4. Signed informed concent

Exclusion Criteria:

1. Acute GVHD grade > II

2. History of psychosis

3. History of asthma

Study Design

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Cannabidiol
Cannabidiol will be dissolved in oil to a predefined concentration.Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.

Locations

Country	Name	City	State
Israel	Davidof Cancer Center, Beilinson 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	Complete resolution of acute GVHD		within 90 days from start of therapy	No
Secondary	Percentage of patients developing chronic GVHD		12 months	No
Secondary	percentage of patients developing > or = grade 3 toxicity		6 months	Yes