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Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

This study is currently recruiting participants.
Verified September 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01596075
First received: May 9, 2012
Last updated: September 9, 2012
Last verified: September 2012
History of Changes
  Purpose

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants 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 be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.


Condition Intervention Phase
Graft Versus Host Disease
 Drug: Cannabidiol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Complete resolution of acute GVHD [ Time Frame: within 90 days from start of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients developing chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • percentage of patients developing > or = grade 3 toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Cannabidiol
Patients undergoing allogeneic SCT will receive standard GVHD prophylaxis consisting of a calcineurin inhibitor and methotrexate or mycophenolate mofetil. Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.
 Drug: Cannabidiol
Cannabidiol will be dissolved in oil to a predefined concentration.Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 18 years
  2. Acute GVHD grade I/II
  3. No history of psychosis
  4. Signed informed concent

Exclusion Criteria:

  1. Acute GVHD grade > II
  2. History of psychosis
  3. History of asthma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596075

Contacts
Contact: Moshe Yeshurun, MD 972-50-4065543 moshey@clalit.org.il
Contact: Ron Ram, MD 972-50-4065621 RonRa@clalit.org.il

Locations
Israel
Davidof Cancer Center, Beilinson hospital, Rabin medical center Recruiting
Petach Tikva, Israel
Contact: Moshe Yeshurun, MD     972-50-4065543     moshey@clalit.org.il    
Contact: Ron Ram, MD     972-50-4065621     RonRa@clalit.org.il    
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: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01596075     History of Changes
Other Study ID Numbers: 0388-11-RMC
Study First Received: May 9, 2012
Last Updated: September 9, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rabin Medical Center:
Cannabidiol
GVHD
Allogeneic transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methylprednisolone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013