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

Phase 1

• Conditions: Graft Versus Host Disease
• Interventions: Drug: Cannabidiol

• Registration Number: NCT01596075
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Study Start: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-09
• Last Update Posted: 2012-09-11
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Cannabidiol	Cannabidiol	Patients undergoing allogeneic SCT will receive standard GVHD prophylaxis consisting of a calcineurin inhibitor and methotrexate or mycophenolate mofetil. 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.

Primary Outcome Measures

Name	Time	Method
Complete resolution of acute GVHD	within 90 days from start of therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of patients developing chronic GVHD	12 months
percentage of patients developing > or = grade 3 toxicity	6 months

Trial Locations

Locations (1)

Davidof Cancer Center, Beilinson hospital, Rabin medical center; 🇮🇱 Petach Tikva, Israel