Trial · NCT01163786
A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
NCT01163786, Phase 2, Terminated, Northwestern University; results first posted 2020-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD. Trials, record NCT01163786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01163786
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
- NCT number
- NCT01163786
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Bronchiolitis Obliterans
- Interventions
- Bortezomib
- First posted
- 2010-07-16
- Last updated
- 2020-04-10
- Results first posted
- 2020-04-10
- Limitations and caveats
- The study was closed before the accrual goal of 20 evaluable patients was reached due to slow accrual.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline | 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. |
| Secondary | Exercise Tolerance- 6 Minute Walk | 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). |
| Secondary | Short Form (SF)-36 Health Survey | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline | Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline | percentage per month | MEDIAN | |
| SECONDARY | Exercise Tolerance- 6 Minute Walk | Up to 18 weeks from baseline | Data was collected but not analyzed due to the study closing before accrual was met. Below is data on how many patients started 6 minute walk and how many patients stopped before reaching 6 minutes at each time point is shown below. | participants | NUMBER |
| SECONDARY | Short Form (SF)-36 Health Survey | up to 18 weeks | Data was collected but not analyzed. Averages for each patient at each timepoint are shown below. N/a is shown for timepoints where data was not collected. | Average Score | NUMBER |
Source ClinicalTrials.gov
Results by group694
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline | Bortezomib | Prior to diagnosis of p-CGVHD | -1.06 | Full Range -5.36 to -0.33 | percentage per month |
| Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline | Bortezomib | During Treatment with Bortezomib | -0.25 | Full Range -9.42 to 3.52 | percentage per month |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 1 (Visit 1): Started 6 Minute walk | 13 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 1 (Visit 1): Stopped before 6 minutes | 3 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 1(Visit 1):Declined walk | 0 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 2 (Visit 5) : Started 6 Minute walk | 3 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 2 (Visit 5) : Stopped before 6 minutes | 0 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Cycle 2(Visit 5):Declined walk | 0 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Follow up/Visit 9: Started 6 Minute walk | 6 | participants | |
| Exercise Tolerance- 6 Minute Walk | Bortezomib | Follow up/Visit 9 : Stopped before 6 minutes | 1 | participants |
1 to 10 of 694Source ClinicalTrials.gov
See all 694 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment With Bortezomib | STARTED | Bortezomib | 17 | |
| Treatment With Bortezomib | Completed 1st Cycle | Bortezomib | 17 | |
| Treatment With Bortezomib | Completed 2nd Cycle | Bortezomib | 14 | |
| Treatment With Bortezomib | COMPLETED | Bortezomib | 14 | |
| Treatment With Bortezomib | NOT COMPLETED | Bortezomib | 3 | |
| Completed Follow up (Visit 9 and 10) | STARTED | Bortezomib | 14 | |
| Completed Follow up (Visit 9 and 10) | Completed Week 12 Follow up (Visit 9) | Bortezomib | 14 | |
| Completed Follow up (Visit 9 and 10) | Completed Week 18 Follow up (Visit 10) | Bortezomib | 13 | |
| Completed Follow up (Visit 9 and 10) | COMPLETED | Bortezomib | 13 | |
| Completed Follow up (Visit 9 and 10) | NOT COMPLETED | Bortezomib | 1 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | Bortezomib | 2 | 17 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Bortezomib | 7 | 17 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Bortezomib | 1 | 17 | |
| other | Platelets | Blood and lymphatic system disorders | Bortezomib | 4 | 17 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Bortezomib | 8 | 17 | |
| other | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | Bortezomib | 3 | 17 | |
| other | Insomnia | General disorders | Bortezomib | 2 | 17 | |
| other | Sweating (diaphoresis) | General disorders | Bortezomib | 1 | 17 | |
| other | Weight gain | General disorders | Bortezomib | 1 | 17 | |
| other | Weight loss | General disorders | Bortezomib | 3 | 17 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bortezomib | 0 | 17 |
| Total, other adverse events | Bortezomib | 17 | 17 |
| Total, serious adverse events | Bortezomib | 3 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01163786
GET https://conductscience.org/api/trials/v1/NCT01163786/results?page=2