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

Phase 2

• Conditions: Graft vs Host Disease
• Interventions: Drug: Cannabidiol; Drug: cyclosporine; Drug: Methotrexate

• Registration Number: NCT02478424
• Lead Sponsor: Rabin Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-23
• Last Update Posted: 2015-06-23
• Study Start: 2015-07
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cannabidiol arm	cyclosporine	Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.
Cannabidiol arm	Cannabidiol	Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.
Cannabidiol arm	Methotrexate	Patients undergoing an allogeneic hematopoietic cell transplantation will be given standard GVHD prophylaxis comprising cyclosporine and a short course of methotrexate plus CBD 150 mg BID starting 7 days before transplantation until day 100.

Primary Outcome Measures

Name	Time	Method
Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100	100 days
grade 3-4 adverse effects attributed to CBD consumption	180 days
Incidence of late onset acute GVHD	12 months
Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Overall survival	12 months
Disease free and immunosuppression free survival by 12 months	12 months
Non relapse mortality	12 months
Relapse rate	12 months
Adherence to study protocol	Until day 100	Percentage of doses actually taken as reported by patients