search
Back to results

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Primary Purpose

Graft Versus Host Disease

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Cannabidiol
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients over 18 years
  2. Acute GVHD grade I/II
  3. No history of psychosis
  4. Signed informed concent

Exclusion Criteria:

  1. Acute GVHD grade > II
  2. History of psychosis
  3. History of asthma

Sites / Locations

  • Davidof Cancer Center, Beilinson hospital, Rabin medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Cannabidiol

Arm Description

Patients undergoing allogeneic SCT will receive standard GVHD prophylaxis consisting of a calcineurin inhibitor and methotrexate or mycophenolate mofetil. Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.

Outcomes

Primary Outcome Measures

Complete resolution of acute GVHD

Secondary Outcome Measures

Percentage of patients developing chronic GVHD
percentage of patients developing > or = grade 3 toxicity

Full Information

First Posted
May 9, 2012
Last Updated
September 9, 2012
Sponsor
Rabin Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01596075
Brief Title
Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
Official Title
Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 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
No

5. Study Description

Brief Summary
Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants 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 be effective for both prevention and treatment of acute 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Cannabidiol
Arm Type
Experimental
Arm Description
Patients undergoing allogeneic SCT will receive standard GVHD prophylaxis consisting of a calcineurin inhibitor and methotrexate or mycophenolate mofetil. Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Description
Cannabidiol will be dissolved in oil to a predefined concentration.Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.
Primary Outcome Measure Information:
Title
Complete resolution of acute GVHD
Time Frame
within 90 days from start of therapy
Secondary Outcome Measure Information:
Title
Percentage of patients developing chronic GVHD
Time Frame
12 months
Title
percentage of patients developing > or = grade 3 toxicity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 18 years Acute GVHD grade I/II No history of psychosis Signed informed concent Exclusion Criteria: Acute GVHD grade > II History of psychosis History of asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshe Yeshurun, MD
Phone
972-50-4065543
Email
moshey@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Ram, MD
Phone
972-50-4065621
Email
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
Davidof Cancer Center, Beilinson 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
Phone
972-50-4065543
Email
moshey@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ron Ram, MD
Phone
972-50-4065621
Email
RonRa@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

We'll reach out to this number within 24 hrs