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Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT01385124
Recruitment Status : Unknown
Verified September 2012 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : June 29, 2011
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Drug: Oral Cannabidiol Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation
Study Start Date : September 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ]

Secondary Outcome Measures :
  1. Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant [ Time Frame: day 100 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing allogeneic stem cell transplantation.
  2. No previous history of psychosis. -

Exclusion Criteria:

  1. Previous history of psychosis.
  2. Consumption of cannabis during the last 2 moths before transplantation. -
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01385124


Contacts
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Contact: Moshe Yeshurun, MD 972-9378127 moshey@clalit.org.il
Contact: Ron Ram, MD 972-9378116 RonRa@clalit.org.il

Locations
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Israel
Davidoff Cancer Center, Beilin hospital, Rabin medical center Recruiting
Petach Tikva, Israel
Principal Investigator: Moshe Yeshurun, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Moshe Yeshurun, MD Davidoff cancer center, Beilinson hospital, Rabin Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01385124     History of Changes
Other Study ID Numbers: 6276
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: September 2012
Keywords provided by Rabin Medical Center:
Cannabidiol
GVHD
Allogeneic transplantation
Prophylaxis
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Epidiolex
Anticonvulsants