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

September 9, 2012 updated by: Rabin Medical Center

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Petach Tikva, Israel
        • Recruiting
        • Davidof Cancer Center, Beilinson hospital, Rabin medical center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete resolution of acute GVHD
Time Frame: within 90 days from start of therapy
within 90 days from start of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients developing chronic GVHD
Time Frame: 12 months
12 months
percentage of patients developing > or = grade 3 toxicity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Moshe Yeshurun, MD, Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 9, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 0388-11-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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