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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Oral cannabidiol at a dose of 150 mg BID up to 90 days.
IV methylprednisolone 2 mg/kg/day
cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)
Davidof Cancer Center, Beilinson hospital, Rabin medical center
Petah Tikva, Israel
Proportion of patients with complete remission of acute GVHD
Time frame: 90 days
Proportion of patients with partial remission of acute GVHD
Time frame: 90 days
Proportion of patients with chronic GVHD
Time frame: 12 months
Proportion of patients able to discontinue immunosuppression
Time frame: 12 months
Transplant related mortality
Time frame: 12 months
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