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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01385124

Enrollment

Registered

2011-06-29

Start date

2012-09-30

Completion date

Unknown

Last updated

2015-06-19

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, Prophylaxis

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.

Interventions

DRUGOral Cannabidiol

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients undergoing allogeneic stem cell transplantation. 2. No previous history of psychosis. -

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Contacts

Primary ContactMoshe Yeshurun, MD

moshey@clalit.org.il972-9378127

Backup ContactRon Ram, MD

RonRa@clalit.org.il972-9378116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026