Eligibility, any sex, with Bronchiolitis Obliterans. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) DeclinePrimary· 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.
Prior to diagnosis of p-CGVHD
Group
Value
95% CI
Bortezomib
-1.06
-5.36 – -0.33
During Treatment with Bortezomib
Group
Value
95% CI
Bortezomib
-0.25
-9.42 – 3.52
Exercise Tolerance- 6 Minute WalkSecondary· 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).
Cycle 1 (Visit 1): Started 6 Minute walk
Group
Value
95% CI
Bortezomib
13
Cycle 1 (Visit 1): Stopped before 6 minutes
Group
Value
95% CI
Bortezomib
3
Cycle 1(Visit 1):Declined walk
Group
Value
95% CI
Bortezomib
0
Cycle 2 (Visit 5) : Started 6 Minute walk
Group
Value
95% CI
Bortezomib
3
Cycle 2 (Visit 5) : Stopped before 6 minutes
Group
Value
95% CI
Bortezomib
0
Cycle 2(Visit 5):Declined walk
Group
Value
95% CI
Bortezomib
0
Follow up/Visit 9: Started 6 Minute walk
Group
Value
95% CI
Bortezomib
6
Follow up/Visit 9 : Stopped before 6 minutes
Group
Value
95% CI
Bortezomib
1
Short Form (SF)-36 Health SurveySecondary· 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
Pt #01 Physical Functioning : Visit 1
Group
Value
95% CI
Bortezomib
30
Pt #01 Physical Functioning : Visit 5
Group
Value
95% CI
Bortezomib
55
Pt #01 Physical Functioning : Visit 8
Group
Value
95% CI
Bortezomib
NA
Pt #01 Physical Functioning : Visit 9
Group
Value
95% CI
Bortezomib
NA
Pt #01 Physical Functioning : Visit 10
Group
Value
95% CI
Bortezomib
NA
Pt #01 Role-physical : Visit 1
Group
Value
95% CI
Bortezomib
0
Pt #01 Role-physical : Visit 5
Group
Value
95% CI
Bortezomib
25
Pt #01 Role-physical : Visit 8
Group
Value
95% CI
Bortezomib
NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Approximately 10,000 allogeneic hematopoietic stem cell transplants (HSCT) are performed annually in the US for various indications. Bronchiolitis obliterans (BO) is the most common late noninfectious complication following allogeneic hematopoietic stem cell transplant. Prognosis of BO in the allogeneic HSCT setting is dismal and there are no therapies proven to be consistently effective. The exact incidence is not clear but may be as high as 30%2 . Risk factors include new or ongoing chronic graft versus host disease (cGVHD), age, antecedent obstructive airways disease and viral infections1. BO is characterized physiologically by progressive irreversible airflow obstruction and pathologically by luminal occlusion of the distal airways due to progressive scarring3. The pathogenesis is not completely understood but the cytokine transforming growth factor-beta 1 (TGF-b1), important for both tissue repair and fibrosis, is thought to play a pivotal role. Bortezomib, an FDA approved proteasomal inhibitor inhibits TGF-b1 signaling in vitro and protects against lung injury/fibrosis in bleomycin mouse model as well as in a mouse model for skin fibrosis. This is consistent with other data in the literature that proteasomal inhibition can prevent the development of fibrosis. Thus the investigators propose to test the safety, tolerability and efficacy of bortezomib in chronic pulmonary GVHD (BO).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 10 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01163786.