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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01596075

Enrollment

Registered

2012-05-10

Start date

2012-07-31

Completion date

Unknown

Last updated

2012-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Versus Host Disease

Keywords

Cannabidiol, GVHD, Allogeneic transplantation

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.

Interventions

DRUGCannabidiol

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Complete resolution of acute GVHD	within 90 days from start of therapy

Secondary

Measure	Time frame
Percentage of patients developing chronic GVHD	12 months
percentage of patients developing > or = grade 3 toxicity	6 months

Countries

Israel

Contacts

Primary ContactMoshe Yeshurun, MD

moshey@clalit.org.il972-50-4065543

Backup ContactRon Ram, MD

RonRa@clalit.org.il972-50-4065621

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026