We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is not yet open for participant recruitment.
Verified March 2015 by moshe yeshurun, Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02392780
First Posted: March 19, 2015
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
moshe yeshurun, Rabin Medical Center
  Purpose
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.

Condition Intervention Phase
Acute-graft-versus-host Disease Drug: Cannabidiol Drug: Methylprednisolone Drug: Calcineurin inhibitor Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease

Resource links provided by NLM:


Further study details as provided by moshe yeshurun, Rabin Medical Center:

Primary Outcome Measures:
  • Proportion of patients with complete remission of acute GVHD [ Time Frame: 90 days ]

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

Other Outcome Measures:
  • 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


Estimated Enrollment: 10
Study Start Date: April 2015
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02392780


Contacts
Contact: Moshe Yeshurun, MD 972-50-4065543 moshey@clalit.org.il
Contact: Liat Shargian, MD 972-54-2394930 LIATSHR@clalit.org.il

Locations
Israel
Davidof Cancer Center, Beilinson hospital, Rabin medical center Not yet recruiting
Petach Tikva, Israel
Contact: Moshe Yeshurun, MD    972-50-4065543    moshey@clalit.org.il   
Contact: Liat Shargian, MD    972-54-2394930    LIATSHR@clalit.org.il   
Sponsors and Collaborators
moshe yeshurun
  More Information

Responsible Party: moshe yeshurun, Head, BMT unit, Rabin Medical Center, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02392780     History of Changes
Other Study ID Numbers: 0009-15-RMC
First Submitted: March 9, 2015
First Posted: March 19, 2015
Last Update Posted: March 19, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Calcineurin Inhibitors
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action