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

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ClinicalTrials.gov Identifier: NCT02478424
Recruitment Status : Unknown
Verified June 2015 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Cannabidiol Drug: cyclosporine Drug: Methotrexate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cannabidiol arm
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

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.

Other Name: CBD

Drug: cyclosporine
Drug: Methotrexate



Primary Outcome Measures :
  1. Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100 [ Time Frame: 100 days ]
  2. grade 3-4 adverse effects attributed to CBD consumption [ Time Frame: 180 days ]
  3. Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months [ Time Frame: 12 months ]
  4. Incidence of late onset acute GVHD [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Non relapse mortality [ Time Frame: 12 months ]
  2. Relapse rate [ Time Frame: 12 months ]
  3. Overall survival [ Time Frame: 12 months ]
  4. Adherence to study protocol [ Time Frame: Until day 100 ]
    Percentage of doses actually taken as reported by patients

  5. Disease free and immunosuppression free survival by 12 months [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478424


Contacts
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Contact: Moshe Yeshurun, MD 972-50-4065543 moshey@clalit.org.il
Contact: Liat Shargian, MD 972-54-2394930 LIATSHR@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02478424     History of Changes
Other Study ID Numbers: RMC-0208-14
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Cyclosporine
Methotrexate
Epidiolex
Cyclosporins
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Anticonvulsants