NCT01596075

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

3 years

First QC Date

May 9, 2012

Last Update Submit

September 9, 2012

Conditions

Graft Versus Host Disease

Keywords

CannabidiolGVHDAllogeneic transplantation

Outcome Measures

Primary Outcomes (1)

  • Complete resolution of acute GVHD

    within 90 days from start of therapy

Secondary Outcomes (2)

  • Percentage of patients developing chronic GVHD

    12 months

  • percentage of patients developing > or = grade 3 toxicity

    6 months

Study Arms (1)

Oral Cannabidiol

EXPERIMENTAL

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.

Drug: Cannabidiol

Interventions

CannabidiolDRUG

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.

Oral Cannabidiol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years
  • Acute GVHD grade I/II
  • No history of psychosis
  • Signed informed concent

You may not qualify if:

  • Acute GVHD grade \> II
  • History of psychosis
  • History of asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davidof Cancer Center, Beilinson hospital, Rabin medical center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Moshe Yeshurun, MD

    Davidoff cancer center, Beilinson hospital, Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

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

Ron Ram, MD

CONTACT

972-50-4065621RonRa@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

IL(1)