Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01385124|
Recruitment Status : Unknown
Verified September 2012 by Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : June 29, 2011
Last Update Posted : June 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: Oral Cannabidiol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2015|
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.
- Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ]
- Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant [ Time Frame: day 100 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385124
|Contact: Moshe Yeshurun, MDemail@example.com|
|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|