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

NCT ID: NCT02392780

Last Updated: 2015-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute-graft-versus-host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cannabidiol

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

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

Methylprednisolone

Intervention Type DRUG

IV methylprednisolone 2 mg/kg/day

Calcineurin inhibitor

Intervention Type 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)

Interventions

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Cannabidiol

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

Intervention Type DRUG

Methylprednisolone

IV methylprednisolone 2 mg/kg/day

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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moshe yeshurun

OTHER

Sponsor Role lead

Responsible Party

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moshe yeshurun

Head, BMT unit, Rabin Medical Center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Davidof Cancer Center, Beilinson hospital, Rabin medical center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Moshe Yeshurun, MD

Role: CONTACT

[email protected]
972-50-4065543

Liat Shargian, MD

Role: CONTACT

[email protected]
972-54-2394930

Facility Contacts

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Moshe Yeshurun, MD

Role: primary

[email protected]
972-50-4065543

Liat Shargian, MD

Role: backup

[email protected]
972-54-2394930

Other Identifiers

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0009-15-RMC

Identifier Type: -

Identifier Source: org_study_id

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