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COMPLETED
NCT03945591
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

Bortezomib

1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.

DRUG

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