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

NCT02478424 | Unknown Phase 2

• 1 other identifier: RMC-0208-14
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (4)

• 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 overall chronic GVHD and moderate to severe chronic GVHD by 12 months

  12 months

• Incidence of late onset acute GVHD

  12 months

Secondary Outcomes (5)

• Non relapse mortality

  12 months

• Relapse rate

  12 months

• Overall survival

  12 months

• Adherence to study protocol

  Until day 100

• Disease free and immunosuppression free survival by 12 months

  12 months

Study Arms (1)

Cannabidiol arm

EXPERIMENTAL

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.

Drug: Cannabidiol; Drug: cyclosporine; Drug: Methotrexate

Interventions

Cannabidiol DRUG

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.

Also known as: CBD

Cannabidiol arm

cyclosporine DRUG

Cannabidiol arm

Methotrexate DRUG

Cannabidiol arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute leukemia in complete remission
• Myeloablative conditioning
• Matched or one antigen or allele mismatched sibling or unrelated donor

You may not qualify if:

• History of psychosis
• Bronchial asthma

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cannabidiol; Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

972-50-4065543; moshey@clalit.org.il

Liat Shargian, MD

CONTACT

972-54-2394930; LIATSHR@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 23, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 23, 2015

Record last verified: 2015-06