A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
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:
- Collect peripheral blood stem cells (PBSCs) from donors for transplant.
- Determine the largest possible dose of bortezomib that can be given to recipients with various blood cancers in a safe manner.
- Monitor the recipient for risk of infection or side affects associated with the transplant.
- Monitor the recipient for increased immunity following transplantation.
|Graft vs Host Disease Peripheral Blood Stem Cell Transplantation Transplantation, Homologous||Drug: Tacrolimus Drug: Sirolimus Drug: Bortezomib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation|
- To evaluate the maximum tolerated dose (MTD) of bortezomib in combination with tacrolimus and sirolimus as GVHD prophylaxis in patients undergoing myeloablative allogeneic peripheral blood stem cell transplantation. [ Time Frame: Baseline through end of study ]
- To assess the toxicity of bortezomib [ Time Frame: Baseline through end of study ]
- To describe engraftment [ Time Frame: Baseline through end of study ]
- To describe the incidence of acute and chronic GVHD [ Time Frame: Baseline through end of study ]
|Study Start Date:||May 2008|
|Study Completion Date:||October 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used:
Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3
Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3
Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670423
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Jennifer Schwartz, MD||Indiana University School of Medicine|