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

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01596075

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease	Drug: Cannabidiol	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral 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.	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.

Arm

Intervention/Treatment

Experimental: Oral 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.

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.

Outcome Measures

Primary Outcome Measures

Complete resolution of acute GVHD [within 90 days from start of therapy]

Secondary Outcome Measures

Percentage of patients developing chronic GVHD [12 months]
percentage of patients developing > or = grade 3 toxicity [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients over 18 years
Acute GVHD grade I/II
No history of psychosis
Signed informed concent

Exclusion Criteria:

Acute GVHD grade > II
History of psychosis
History of asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Davidof Cancer Center, Beilinson hospital, Rabin medical center	Petach Tikva		Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Moshe Yeshurun, MD, Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT01596075

Other Study ID Numbers:

0388-11-RMC

First Posted:

May 10, 2012

Last Update Posted:

Sep 11, 2012

Last Verified:

Sep 1, 2012

Keywords provided by Rabin Medical Center

Cannabidiol

GVHD

Allogeneic transplantation

Additional relevant MeSH terms:

Graft vs Host Disease

Cannabidiol

Study Results

No Results Posted as of Sep 11, 2012