Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease |
Drug: Oral Cannabidiol |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing allogeneic stem cell transplantation.
- No previous history of psychosis. -
Exclusion Criteria:
- Previous history of psychosis.
- Consumption of cannabis during the last 2 moths before transplantation. -
Contacts and Locations| Contact: Moshe Yeshurun, MD | 972-9378127 | moshey@clalit.org.il |
| Contact: Ron Ram, MD | 972-9378116 | RonRa@clalit.org.il |
| Israel | |
| 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 |
More Information
No publications provided
| Responsible Party: | Moshe Yeshurun, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01385124 History of Changes |
| Other Study ID Numbers: | 6276 |
| Study First Received: | June 28, 2011 |
| Last Updated: | September 9, 2012 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Rabin Medical Center:
|
Cannabidiol GVHD Allogeneic transplantation Prophylaxis |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013