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

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ClinicalTrials.gov Identifier: NCT01596075
Recruitment Status : Unknown
Verified September 2012 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : September 11, 2012
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Estimated Primary Completion Date : July 2015


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Complete resolution of acute GVHD [ Time Frame: within 90 days from start of therapy ]

Secondary Outcome Measures :
  1. Percentage of patients developing chronic GVHD [ Time Frame: 12 months ]
  2. percentage of patients developing > or = grade 3 toxicity [ Time Frame: 6 months ]


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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 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

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): 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

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01596075     History of Changes
Other Study ID Numbers: 0388-11-RMC
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents