CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Bortezomib +1 moredrug
Likely dose
Bortezomib 1.3 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03945591
NCT03945591Phase 2Completed
CompareCT.gov

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)

NYU Langone Health·interventional·Posted May 10, 2019·Updated Apr 23, 2026

In Brief

A Phase 2 clinical trial evaluating Bortezomib and Cyclophosphamide for GVHD. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGVHD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMay 10, 2019
Enrollment StartJun 20, 2019
Primary CompletionDec 29, 2022
Study CompletionJan 4, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.1 years ago

Interventions

Bortezomibdrug

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

Cyclophosphamidedrug

50 mg/kg IV over 2 hours on Day +3 and +4