drugset / Trial / NCT02392780
Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease
NaSingle-groupOpen-labelTreatment
Summary
Graft-versus-host-disease (GVHD) is a major obstacle to successful allogeneic hematopoietic cell transplantation (alloHCT). Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent phase 2 study, CBD has been shown to be safe and reduced significantly the incidence of acute GVHD compared to control patients with a hazard ratio of 0.3. Based on these results the investigators propose a phase 2 study to explore the efficacy of oral CBD in the treatment of severe (grades III/IV) acute GVHD, a pathology with a dismal prognosis.
Timeline
- Start
- 2015-04
- Primary completion
- 2018-04
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 150 mg | Oral |
| Background | Cyclosporine | Peptide | — | — |
| Background | Methylprednisolone | Other / unclassified | 2 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | — | — |