A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
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|ClinicalTrials.gov Identifier: NCT01163786|
Recruitment Status : Terminated (Study was closed due to low accrual before the accrual goal was reached)
First Posted : July 16, 2010
Results First Posted : April 10, 2020
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans||Drug: Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 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|
|Actual Study Start Date :||October 7, 2010|
|Actual Primary Completion Date :||September 9, 2015|
|Actual Study Completion Date :||September 9, 2015|
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 Forced Expiratory Volume in 1 Second (FEV1) Decline [ Time Frame: Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline ]FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.
- Exercise Tolerance- 6 Minute Walk [ Time Frame: Up to 18 weeks from baseline ]Patients will have an exercise tolerance assessment defined as a 6 minute walk completed at cycle 1 (week 1) and cycle 2 (week 5) of treatment and visit 9 (12 weeks) and visit 10 (18 weeks).
- Short Form (SF)-36 Health Survey [ Time Frame: up to 18 weeks ]
This is a quality of life questionnaire which yields scores for 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). This questionnaire will be completed by patients on Visit 1 (week 1), Visit 5 (week 5), Visit 8 (week 8), Visit 9 (12 weeks), and Visit 10 (18 weeks).
Questionnaires were scored per the scoring rules for the RAND 36-Item Health Survey (version 1.0) A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.
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|