Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

March 18, 2015 updated by: moshe yeshurun
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

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 18 years or older
  2. After allogeneic transplantation
  3. Grade III or IV acute GVHD
  4. No psychiatric contra-indication
  5. Informed consent

Exclusion Criteria:

  1. History of psychosis
  2. Asthma
  3. Known allergy to cannabis constituents

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: Cannabidiol
Drug: Cannabidiol
Oral cannabidiol at a dose of 150 mg BID up to 90 days.
Drug: Methylprednisolone
IV methylprednisolone 2 mg/kg/day
Drug: Calcineurin inhibitor
cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with complete remission of acute GVHD
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with partial remission of acute GVHD
Time Frame: 90 days
90 days
Proportion of patients with chronic GVHD
Time Frame: 12 months
12 months
Proportion of patients able to discontinue immunosuppression
Time Frame: 12 months
12 months
Transplant related mortality
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subpopulations of peripheral blood cells and cytokine levels
Time Frame: 12 months
T4, T8, Foxp3 T regulatory cells, TNFα, INFγ, IL-1β, IL-6, IL-17, IL-4, IL-5, IL-10 and IL-13
12 months

Collaborators and Investigators

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

Sponsor

moshe yeshurun

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

April 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0009-15-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.

Clinical Trials on Acute-graft-versus-host Disease

Clinical Trials on Cannabidiol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe