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Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Primary Purpose

Graft Versus Host Disease

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Oral Cannabidiol

About this trial

This is an interventional prevention trial for Graft Versus Host Disease focused on measuring Cannabidiol, GVHD, Allogeneic transplantation, Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing allogeneic stem cell transplantation.
No previous history of psychosis. -

Exclusion Criteria:

Previous history of psychosis.
Consumption of cannabis during the last 2 moths before transplantation. -

Sites / Locations

Davidoff Cancer Center, Beilin hospital, Rabin medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Cannabidiol

Arm Description

Oral Cannabidiol 10 mg twice daily will be given from conditioning starting day and until day +30 after allogeneic transplantation. Dose can be doubled every 7 days if no significant side effects documented.

Outcomes

Primary Outcome Measures

Overall percentage of patients with acute GVHD at day 100 post-transplant

Secondary Outcome Measures

Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant

Full Information

NCT ID

NCT01385124

First Posted

June 28, 2011

Last Updated

June 18, 2015

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01385124

Brief Title

Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Official Title

Safety and Efficacy of Oral Cannabidiol for GVHD Prophylaxis in Allogeneic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant 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 reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft Versus Host Disease

Keywords

Cannabidiol, GVHD, Allogeneic transplantation, Prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Cannabidiol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oral Cannabidiol

Intervention Description

Cannabidiol will be dissolved in oil to a predefined concentration. Patients will be given oral cannabidiol 10 mg twice daily from conditioning starting day and until day +30 after allogeneic transplantation.

Primary Outcome Measure Information:

Title

Overall percentage of patients with acute GVHD at day 100 post-transplant

Time Frame

day 100

Secondary Outcome Measure Information:

Title

Percentage of patients with grade III/IV acute GVHD at day 100 post-transplant

Time Frame

day 100

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing allogeneic stem cell transplantation. No previous history of psychosis. - Exclusion Criteria: Previous history of psychosis. Consumption of cannabis during the last 2 moths before transplantation. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moshe Yeshurun, MD

Phone

972-9378127

moshey@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Ron Ram, MD

Phone

972-9378116

RonRa@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Yeshurun, MD

Organizational Affiliation

Davidoff cancer center, Beilinson hospital, Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Davidoff Cancer Center, Beilin hospital, Rabin medical center

City

Petach Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Yeshurun, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26033282

Citation

Yeshurun M, Shpilberg O, Herscovici C, Shargian L, Dreyer J, Peck A, Israeli M, Levy-Assaraf M, Gruenewald T, Mechoulam R, Raanani P, Ram R. Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study. Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.

Results Reference

derived

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Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

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