Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease

Graft vs Host Disease Clinical Trial

Official title:

Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02478424
• Other study ID #: RMC-0208-14
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 15, 2015
• Last updated: June 22, 2015
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2015
• Source: Rabin Medical Center
• Contact: Moshe Yeshurun, MD
• Phone: 972-50-4065543
• Email: moshey[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.

The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute leukemia in complete remission

2. Myeloablative conditioning

3. Matched or one antigen or allele mismatched sibling or unrelated donor

Exclusion Criteria:

1. History of psychosis

2. Bronchial asthma

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft vs Host Disease

Intervention

Drug:
• Cannabidiol
Patients will receive standard GVHD prophylaxis consisting of cyclosporine A twice daily starting on day -1 with target trough levels of 200-400 ng/mL and a short course of methotrexate (15 mg/ m2 on day 1 and 10 mg/ m2 on days days 3 and 6). Patients transplanted from unrelated donors will receive ATG Fresenius at a low dose of 5 mg/kg on days -3 to -1. Patients will be given oral CBD 150 mg BID starting 7 days before transplantation until day 100.
• cyclosporine

• Methotrexate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100		100 days	No
Primary	grade 3-4 adverse effects attributed to CBD consumption		180 days	Yes
Primary	Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months		12 months	No
Primary	Incidence of late onset acute GVHD		12 months	No
Secondary	Non relapse mortality		12 months	Yes
Secondary	Relapse rate		12 months	No
Secondary	Overall survival		12 months	No
Secondary	Adherence to study protocol	Percentage of doses actually taken as reported by patients	Until day 100	No
Secondary	Disease free and immunosuppression free survival by 12 months		12 months	No