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High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Sponsor: NYU Langone Health
Summary
This is a single arm open label phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from matched-related or unrelated donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD prophylaxis.
Official title: A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2019-06-20
Completion Date
2024-01-04
Last Updated
2026-04-23
Healthy Volunteers
No
Conditions
Interventions
Bortezomib
1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide
50 mg/kg IV over 2 hours on Day +3 and +4
Locations (1)
New York University School of Medicine
New York, New York, United States