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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

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date June 23, 2015
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • Incidence of grade 2-4 and grade 3-4 acute GVHD by day 100 [ Time Frame: 100 days ]
  • grade 3-4 adverse effects attributed to CBD consumption [ Time Frame: 180 days ]
  • Incidence of overall chronic GVHD and moderate to severe chronic GVHD by 12 months [ Time Frame: 12 months ]
  • Incidence of late onset acute GVHD [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • Non relapse mortality [ Time Frame: 12 months ]
  • Relapse rate [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Adherence to study protocol [ Time Frame: Until day 100 ]
    Percentage of doses actually taken as reported by patients
  • Disease free and immunosuppression free survival by 12 months [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease
Official Title  ICMJE Extended Use of Cannabidiol for the Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Graft vs Host Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: Cannabidiol
  • Drug: cyclosporine
  • Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478424
Other Study ID Numbers  ICMJE RMC-0208-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP