Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01596075|
Recruitment Status : Unknown
Verified September 2012 by Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : May 10, 2012
Last Update Posted : September 11, 2012
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||July 2012|
|Estimated Primary Completion Date :||July 2015|
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.
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.
- Complete resolution of acute GVHD [ Time Frame: within 90 days from start of therapy ]
- Percentage of patients developing chronic GVHD [ Time Frame: 12 months ]
- percentage of patients developing > or = grade 3 toxicity [ Time Frame: 6 months ]
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): NCT01596075
|Contact: Moshe Yeshurun, MDfirstname.lastname@example.org|
|Contact: Ron Ram, MD||972-50-4065621||RonRa@clalit.org.il|
|Principal Investigator:||Moshe Yeshurun, MD||Davidoff cancer center, Beilinson hospital, Rabin Medical Center|