A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
Information source: Indiana University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft vs Host Disease; Peripheral Blood Stem Cell Transplantation; Transplantation, Homologous
Intervention: Tacrolimus (Drug); Sirolimus (Drug); Bortezomib (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Jennifer E. Schwartz Official(s) and/or principal investigator(s): Jennifer Schwartz, MD, Principal Investigator, Affiliation: Indiana University School of Medicine
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.
Clinical Details
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
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: To assess the toxicity of bortezomibTo describe engraftment To describe the incidence of acute and chronic GVHD
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States
Additional Information
Clinical Trial Flowcharts. Click "Bone Marrow & Stem Cell Transplant"
Starting date: May 2008
Last updated: January 26, 2015
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