Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study
Before your transplant you will receive conditioning therapy with fludarabine and busulfan
given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood
cells taken from your sibling or unrelated donor.
You will receive 3 drugs for your GVHD prophylaxis:
Tacrolimus will be started 3 days before your transplant. It will be given intravenously and
later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.
Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.
Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4,
7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood
work, and be asked to complete a questionnaire.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the incidence of grade II-IV acute GVHD by day 100 after stem cell infusion
John Koreth, MBBS, DPhil
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|