Clinical Trial

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Recruiting Phase 1/2
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Summary
The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-11-07.
Trial Details
NCT Number NCT06681922
Lead Sponsor Northwell Health
Conditions Graft Vs Host Disease
Enrollment 10 participants
Start Date 2024-09-23
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2024-12-16