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

NCT ID: NCT01385124

Last Updated: 2015-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30

Brief 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.

Conditions

Graft Versus Host Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral Cannabidiol

Oral Cannabidiol 10 mg twice daily will be given from conditioning starting day and until day +30 after allogeneic transplantation. Dose can be doubled every 7 days if no significant side effects documented.

Group Type: EXPERIMENTAL

Oral Cannabidiol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Yeshurun, MD

Role: PRINCIPAL_INVESTIGATOR

Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Locations

Davidoff Cancer Center, Beilin hospital, Rabin medical center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Moshe Yeshurun, MD

Role: CONTACT

moshey@clalit.org.il

972-9378127

Ron Ram, MD

Role: CONTACT

RonRa@clalit.org.il

972-9378116

References

Yeshurun M, Shpilberg O, Herscovici C, Shargian L, Dreyer J, Peck A, Israeli M, Levy-Assaraf M, Gruenewald T, Mechoulam R, Raanani P, Ram R. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.

Reference Type: DERIVED

PMID: 26033282 (View on PubMed)

Other Identifiers

6276

Identifier Type: -

Identifier Source: org_study_id