Clinical Trial NU 09H7
- A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
- Principal Investigator
- Manu Jain
- Status: CLOSED
- Study Type: Therapeutic, Symptom Management
- Protocol No:.NU 09H7
- The purpose of a phase 2 study is to determine the efficacy, safety and tolerability of intravenous bortezomib in patients with pulmonary GVHD after allogeneic HSCT.
- Bronchiolitis obliterans (BO) is the most common late complication that effects the lungs in patients that have had hematopoietic stem cell transplant (HSCT), in which the donor cells are from another person. BO leads to permanent airway obstruction due to scarring of the lung air passages and is thought to be the primary lung complication when the transplanted donor immune cells attack the organs of the patient. This is called graft versus host disease (GVHD). There are currently no proven therapies available to treat this disease. Velcade™ (bortezomib) is a medication currently approved in the United States for the treatment of multiple myeloma and lymphoma but not for (BO). Preliminary laboratory data suggests that this medication inhibits effects of TGF-beta1 which is thought to be a key factor in scarring.
Some of the eligibility criteria include:
- Patients must have had an allogeneic hematopoietic stem cell transplantation at least 100 days prior to the study.
- Participants must have underlying cancer in remission.
- Participants must not have received other investigational drugs within 14 days of study enrollment.
- Participants must have bronciolitis obliterans.
- Description of Treatment
- Participation in this study will last for up to 5 months and will involve 10 visits, each lasting between one and two hours. The study drug Velcade will be given intravenously (through a vein) in the arm on visits 1-9. During the study participants will also complete quality of life questionnaires and will have their lung function measured periodically..
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 03-May-16 01:53 AM
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