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

Clalit Health Services

Status and phase: Unknown; Phase 2

Conditions: Graft vs Host Disease

Treatments: Drug: Methotrexate; Drug: Cannabidiol; Drug: cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT02478424

RMC-0208-14

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cannabidiol arm

Experimental group

Description:

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.

Treatment:

Drug: Cannabidiol

Drug: Methotrexate

Drug: cyclosporine