Clinical trial NCT00670423: A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Graft vs Host Disease
Peripheral Blood Stem Cell Transplantation
Transplantation, Homologous
Keywords: Tacrolimus
Sirolimus
Bortezomib
Acute Graft Versus Host Disease
Allogeneic Peripheral Blood Stem Cell Transplantation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2008-05-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Baseline through end of study
Secondary outcomes:
measure: To assess the toxicity of bortezomib
timeFrame: Baseline through end of study
measure: To describe engraftment
timeFrame: Baseline through end of study
measure: To describe the incidence of acute and chronic GVHD
timeFrame: Baseline through end of study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Jennifer Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: