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Biol Blood Marrow Transplant. 2015 Oct;21(10):1770-5. doi: 10.1016/j.bbmt.2015.05.018. Epub 2015 May 30.

Cannabidiol for the Prevention of Graft-versus-Host-Disease after Allogeneic Hematopoietic Cell Transplantation: Results of a Phase II Study.

Author information

  • 1Bone Marrow Transplantation Unit, Institute of Hematology, Davidoff Center, Beilinson Hospital, Rabin Medical Center, Petah-Tikva, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: moshe.yeshurun@gmail.com.
  • 2Bone Marrow Transplantation Unit, Institute of Hematology, Davidoff Center, Beilinson Hospital, Rabin Medical Center, Petah-Tikva, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • 3Bone Marrow Transplantation Unit, Institute of Hematology, Davidoff Center, Beilinson Hospital, Rabin Medical Center, Petah-Tikva, Israel.
  • 4Tissue Typing Laboratory, Rabin Medical Center, Petah-Tikva, Israel.
  • 5Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel; Felsenstein Medical Research Center, Beilinson Hospital, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • 6Pharmacy Services, Rabin Medical Center, Petah-Tikva, Israel.
  • 7Institute for Drug Research, Medical Faculty, Hebrew University, Jerusalem, Israel.

Abstract

Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a nonpsychotropic ingredient of Cannabis sativa, possesses potent anti-inflammatory and immunosuppressive properties. We hypothesized that CBD may decrease GVHD incidence and severity after alloHCT. We conducted a phase II study. GVHD prophylaxis consisted of cyclosporine and a short course of methotrexate. Patients transplanted from an unrelated donor were given low-dose anti-T cell globulin. CBD 300 mg/day was given orally starting 7 days before transplantation until day 30. Forty-eight consecutive adult patients undergoing alloHCT were enrolled. Thirty-eight patients (79%) had acute leukemia or myelodysplastic syndrome and 35 patients (73%) were given myeloablative conditioning. The donor was either an HLA-identical sibling (n = 28), a 10/10 matched unrelated donor (n = 16), or a 1-antigen-mismatched unrelated donor (n = 4). The median follow-up was 16 months (range, 7 to 23). No grades 3 to 4 toxicities were attributed to CBD. None of the patients developed acute GVHD while consuming CBD. In an intention-to-treat analysis, we found that the cumulative incidence rates of grades II to IV and grades III to IV acute GVHD by day 100 were 12.1% and 5%, respectively. Compared with 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grades II to IV acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was .3 (P = .0002). Rates of nonrelapse mortality at 100 days and at 1 year after transplantation were 8.6% and 13.4%, respectively. Among patients surviving more than 100 days, the cumulative incidences of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively. The combination of CBD with standard GVHD prophylaxis is a safe and promising strategy to reduce the incidence of acute GVHD. A randomized double-blind controlled study is warranted. (clinicaltrials.gov: NCT01385124).

Copyright © 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

KEYWORDS:

Allogeneic hematopoietic cell transplantation; Cannabidiol; Cannabis sativa; Graft-versus-host disease; Prophylaxis

PMID:
26033282
[PubMed - in process]
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