- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01596075
Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Ron Ram, MD
- Phone Number: 972-50-4065621
- Email: RonRa@clalit.org.il
Study Locations
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-
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Petach Tikva, Israel
- Recruiting
- Davidof Cancer Center, Beilinson hospital, Rabin medical center
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Contact:
- Ron Ram, MD
- Phone Number: 972-50-4065621
- Email: RonRa@clalit.org.il
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients over 18 years
- Acute GVHD grade I/II
- No history of psychosis
- Signed informed concent
Exclusion Criteria:
- Acute GVHD grade > II
- History of psychosis
- History of asthma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete resolution of acute GVHD
Time Frame: within 90 days from start of therapy
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within 90 days from start of therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients developing chronic GVHD
Time Frame: 12 months
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12 months
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percentage of patients developing > or = grade 3 toxicity
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moshe Yeshurun, MD, Davidoff cancer center, Beilinson hospital, Rabin Medical Center
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0388-11-RMC
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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