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Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study
A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD. In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
May 1, 2011
Primary Completion Date
February 1, 2013
Completion Date
November 1, 2013
Last Updated
May 30, 2017
35
ACTUAL participants
Bortezomib
DRUG
Tacrolimus
DRUG
Methotrexate
DRUG
Lead Sponsor
Dana-Farber Cancer Institute
NCT05529069
NCT00106925
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