A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
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|ClinicalTrials.gov Identifier: NCT01163786|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2010
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans||Drug: Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Patients will Receive 2 4week cycles of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.
Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib wil be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Other Name: Velcade
- Change in pulmonary function as measured by FEV1 from baseline and 9 weeks later. [ Time Frame: 9 weeks ]Research subjects will receive 2 4 week cycles of bortezomib with a 1 week holiday between cycles.
- Exercise Tolerance- 6 minute walk at baseline and 9 weeks later. [ Time Frame: 9 weeks ]
- Quality of Life-SF-36 at baseline and 9 weeks later. [ Time Frame: 9 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163786
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Manu Jain, MD, MS||Northwestern University|
|Principal Investigator:||Jayesh Mehta, MD||Northwestern University|