Status:
COMPLETED
A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
Lead Sponsor:
Jennifer E. Schwartz
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Graft vs Host Disease
Peripheral Blood Stem Cell Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 caus...
Eligibility Criteria
Inclusion
- Undergoing myeloablative peripheral blood stem cell transplantation
- Have an HLA matched-related or matched-unrelated donor (9/10 antigen or allelic mismatch or 10/10 HLA match permitted).
- Hematological malignancy including patients with: AML, ALL, NHL, Hodgkin's Disease, CLL, CML, MDS and Multiple Myeloma
- Meeting institutional standard criteria for allogeneic PBSC transplantation
Exclusion
- Patient has \>Grade 2 peripheral neuropathy within 14 days before enrollment.
- History of autologous or allogeneic transplantation
- Evidence of HIV seropositivity
- Evidence of active infection
- Patients with cardiac dysfunction as described in the protocol
- Patients with hypersensitivity to bortezomib, boron or mannitol
Key Trial Info
Start Date :
May 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00670423
Start Date
May 16 2008
End Date
October 16 2013
Last Update
August 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202