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

NCT02392780 | Unknown Phase 2 DMC

• 1 other identifier: 0009-15-RMC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute-graft-versus-host Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete remission of acute GVHD

  90 days

Secondary Outcomes (4)

• Proportion of patients with partial remission of acute GVHD

  90 days

• Proportion of patients with chronic GVHD

  12 months

• Proportion of patients able to discontinue immunosuppression

  12 months

• Transplant related mortality

  12 months

Other Outcomes (1)

• Subpopulations of peripheral blood cells and cytokine levels

  12 months

Study Arms (1)

Cannabidiol

EXPERIMENTAL

Drug: Cannabidiol; Drug: Methylprednisolone; Drug: Calcineurin inhibitor

Interventions

Cannabidiol DRUG

Oral cannabidiol at a dose of 150 mg BID up to 90 days.

Cannabidiol

Methylprednisolone DRUG

IV methylprednisolone 2 mg/kg/day

Cannabidiol

Calcineurin inhibitor DRUG

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)

Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• After allogeneic transplantation
• Grade III or IV acute GVHD
• No psychiatric contra-indication
• Informed consent

You may not qualify if:

• History of psychosis
• Asthma
• Known allergy to cannabis constituents

Sponsors & Collaborators

• moshe yeshurun: lead

Study Sites (1)

Davidof Cancer Center, Beilinson hospital, Rabin medical center

Petah Tikva, Israel

Location

MeSH Terms

Interventions

Cannabidiol; Methylprednisolone; Calcineurin Inhibitors

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

972-50-4065543; moshey@clalit.org.il

Liat Shargian, MD

CONTACT

972-54-2394930; LIATSHR@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, BMT unit, Rabin Medical Center

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 19, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Last Updated: March 19, 2015

Record last verified: 2015-03

Locations

IL (1)