- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385124
Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Moshe Yeshurun, MD
- Phone Number: 972-9378127
- Email: moshey@clalit.org.il
Study Contact Backup
- Name: Ron Ram, MD
- Phone Number: 972-9378116
- Email: RonRa@clalit.org.il
Study Locations
-
-
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Petach Tikva, Israel
- Recruiting
- Davidoff Cancer Center, Beilin hospital, Rabin medical center
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Principal Investigator:
- Moshe Yeshurun, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall percentage of patients with acute GVHD at day 100 post-transplant
Time Frame: day 100
|
day 100
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant
Time Frame: day 100
|
day 100
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moshe Yeshurun, MD, Davidoff cancer center, Beilinson hospital, Rabin Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6276
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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