- ICH GCP
- US Clinical Trials Registry
- 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
August 14, 2018 updated by: Jennifer E. Schwartz
A Phase I Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline through end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the toxicity of bortezomib
Time Frame: Baseline through end of study
|
Baseline through end of study
|
To describe engraftment
Time Frame: Baseline through end of study
|
Baseline through end of study
|
To describe the incidence of acute and chronic GVHD
Time Frame: Baseline through end of study
|
Baseline through end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Schwartz, MD, Indiana University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2008
Primary Completion (Actual)
July 5, 2012
Study Completion (Actual)
October 16, 2013
Study Registration Dates
First Submitted
April 29, 2008
First Submitted That Met QC Criteria
April 30, 2008
First Posted (Estimate)
May 1, 2008
Study Record Updates
Last Update Posted (Actual)
August 16, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Graft vs Host Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Calcineurin Inhibitors
- Bortezomib
- Tacrolimus
- Sirolimus
Other Study ID Numbers
- IUCRO-0204
- 0803-17 (Other Identifier: Indiana University IRB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Taro Pharmaceuticals USACompleted
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Peking Union Medical College HospitalUnknown
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Technical University of MunichCompleted
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Limerick BioPharmaCompleted
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University of British ColumbiaPaladin Labs Inc.RecruitingLiver Transplantation | Neurotoxicity | Tremor | Tacrolimus | ImmunosuppressionCanada