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

NCT01385124 | Unknown Phase 1

• 1 other identifier: 6276
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease

Keywords

Cannabidiol; GVHD; Allogeneic transplantation; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Overall percentage of patients with acute GVHD at day 100 post-transplant

  day 100

Secondary Outcomes (1)

• Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant

  day 100

Study Arms (1)

Oral Cannabidiol

EXPERIMENTAL

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

Interventions

Oral Cannabidiol DRUG

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.

Oral Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous history of psychosis.
• Consumption of cannabis during the last 2 moths before transplantation. -

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Davidoff Cancer Center, Beilin hospital, Rabin medical center

Petah Tikva, Israel

RECRUITING

Related Publications (1)

• Yeshurun M, Shpilberg O, Herscovici C, Shargian L, Dreyer J, Peck A, Israeli M, Levy-Assaraf M, Gruenewald T, Mechoulam R, Raanani P, Ram R. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.

  PMID: 26033282 DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Moshe Yeshurun, MD

  Davidoff cancer center, Beilinson hospital, Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

972-9378127; moshey@clalit.org.il

Ron Ram, MD

CONTACT

972-9378116; RonRa@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: September 1, 2012
• Primary Completion: December 1, 2015
• Last Updated: June 19, 2015

Record last verified: 2012-09

Locations

IL (1)