A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation

• Status: Completed
• Trial end date: 2013-10-16

Summary

The purpose of this study is determine the highest dose of bortezomib, a new drug for graft-versus host disease prevention, that can be given in combination with sirolimus and Tacrolimus, without causing severe side effects. This research is being done because there is no treatment that is 100% effective in preventing graft versus host disease.

The goals of this study are to:

1. Collect peripheral blood stem cells (PBSCs) from donors for transplant.

2. Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.

3. Monitor the recipient for risk of infection or side affects associated with the transplant.

4. Monitor the recipient for increased immunity following transplantation.

• Phase: Phase 1

Details

• Lead Sponsor: Jennifer E. Schwartz
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib; Everolimus; Sirolimus; Tacrolimus