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:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01385124
First received: June 28, 2011
Last updated: September 9, 2012
Last verified: September 2012

June 28, 2011
September 9, 2012
September 2012
September 2014   (final data collection date for primary outcome measure)
Overall percentage of patients with acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01385124 on ClinicalTrials.gov Archive Site
Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant [ Time Frame: day 100 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Graft Versus Host Disease
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2015
September 2014   (final data collection date for primary outcome measure)

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. -
Both
18 Years and older
No
Contact: Moshe Yeshurun, MD 972-9378127 moshey@clalit.org.il
Contact: Ron Ram, MD 972-9378116 RonRa@clalit.org.il
Israel
 
NCT01385124
6276
No
Moshe Yeshurun, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Moshe Yeshurun, MD Davidoff cancer center, Beilinson hospital, Rabin Medical Center
Rabin Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP