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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Rabin Medical Center
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01385124
First received: June 28, 2011
Last updated: September 9, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385124

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

Locations
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
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 September 30, 2014