Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation
This study is currently recruiting participants.
Verified September 2012 by Rabin Medical Center
Sponsor:
Rabin Medical Center
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01385124
First received: June 28, 2011
Last updated: September 9, 2012
Last verified: September 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 28, 2011 | ||||||||
| Last Updated Date | September 9, 2012 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01385124 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation | ||||||||
| Official Title ICMJE | Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation | ||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Graft Versus Host Disease | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | 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.
Intervention: Drug: Oral Cannabidiol |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | April 2015 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01385124 | ||||||||
| Other Study ID Numbers ICMJE | 6276 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Moshe Yeshurun, Rabin Medical Center | ||||||||
| Study Sponsor ICMJE | Rabin Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rabin Medical Center | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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