Phase I-II Study of High-Dose Cyclophosphamide, Bortezomib, and Abatacept to Prevent Graft-versus-Host Disease After Allogeneic Stem Cell Transplant

What this Trial Is About

This research aims to evaluate the prevention of graft-versus-host disease GvHD in adults with blood cancers undergoing allogeneic hematopoietic stem cell transplantation HSCT. It is a phase I-II clinical trial that includes patients receiving stem cells from either an HLA matched sibling or a closely matched unrelated donor. The study seeks to define the highest safe dose of abatacept combined with post-transplant cyclophosphamide and bortezomib and to assess this combinations effect on reducing GvHD. Participants will receive a standard conditioning treatment before transplant, followed by peripheral blood stem cell infusion. Those with unrelated donors will also get rabbit anti-thymocyte globulin. The trial has a phase I dose-escalation part to find the maximum tolerated dose of abatacept and a phase II part with two groups based on donor type. All subjects will receive investigational post-transplant cyclophosphamide, bortezomib, and abatacept to prevent GvHD. During the study, participants will be closely monitored for side effects and incidence of acute and chronic GvHD, graft failure, survival rates, and relapse over periods ranging from one month up to two years. Safety and effectiveness data will be collected through regular clinical assessments and laboratory tests. Participants will be followed for up to 730 days to evaluate outcomes such as treatment-related mortality and overall survival.

Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD)