NCT00670423

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jennifer E. Schwartz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft vs Host Disease
• Peripheral Blood Stem Cell Transplantation
• Transplantation, Homologous

Interventions

Type	Name	Description
DRUG	Tacrolimus	Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL)
DRUG	Sirolimus	Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL)
DRUG	Bortezomib	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

Timeline

• Start date: 2008-05-16
• Primary completion: 2012-07-05
• Completion: 2013-10-16
• First posted: 2008-05-01
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study