Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation|
- Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
- Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385124
|Contact: Moshe Yeshurun, MDfirstname.lastname@example.org|
|Contact: Ron Ram, MD||972-9378116||RonRa@clalit.org.il|
|Davidoff Cancer Center, Beilin hospital, Rabin medical center||Recruiting|
|Petach Tikva, Israel|
|Principal Investigator: Moshe Yeshurun, MD|
|Principal Investigator:||Moshe Yeshurun, MD||Davidoff cancer center, Beilinson hospital, Rabin Medical Center|