An open label, study to evaluate the safety of Cannabidiol (CBD) for the prevention of Acute Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic cell transplantation.

Phase 2

Recruiting

• Conditions: Acute Graft Versus Host Disease; Hematopoietic Stem Cell Transplantation; Cancer - Other cancer types; Blood - Haematological diseases

• Registration Number: ACTRN12619000623190
• Lead Sponsor: Kalytera Therapeutics Israel Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-26
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Any malignant hematological disease in CR or Myelodysplastic Syndrome (MDS)
2.Age greater than or equal to 18 years
3.Karnofsky Score (KS) greater than or equal to 60%
4.HSCT-Comorbidity Index (HSCT-CI) score less than or equal to 3
5.No major organ dysfunction
6.Myeloablative or reduced intensity conditioning regimen
7.matched (7/8 or 8/8) unrelated donor
8.Peripheral blood stem cell graft
9.Subject’s written informed consent

Exclusion Criteria

1.Malignant hematological disease, other than MDS, not in CR
2.Myelofibrosis
3.Allogeneic transplantation from a matched or mismatched sibling donor
4.Cord blood transplantation
5.Positive serology for HIV
6.Serious psychiatric or psychological disorders
7.Any uncontrolled infection at time of registration
8. Study subjects must not be pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the trial, as well as within 30 days after the anticipated date the subjects would complete the study.
9.Active consumption of illicit drugs (such as: Crack cocaine, Heroin, Methamphetamines, Cocaine, Bath Salts, Amphetamines, Methadone, Benzodiazepine, Marijuana, Ecstasy)
10. Use of Cannabis and/or its derivatives fourteen days prior to HSCT and for the duration of study participation
11. QTc greater than 450ms per Friderica's correction and impaired cardiac function or clinically significant cardiac disease
12. Inadequate renal function defined as measured creatinine clearance greater than 2.0 mg/dl
13. Liver enzymes: ALT and AST greater than 3 times the upper limit of normal
14. Pregnant or breastfeeding (positive serum beta-HCG 7 days before first dose)
15. Treatment with another investigational drug, biological agent, or device within 30 days of first dose, or investigational cell therapy within 6 months of first dose..

Study & Design

• Study Type: Interventional
• Study Design: Not specified