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
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Bortezomib
Patients will Receive 2 4week cycles of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles.
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Drug: Bortezomib
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
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- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Day >100 after allogeneic hematopoietic stem cell transplantation
- Underlying cancer in remission
- Decrease in FEV1 of ≥12% from the pre-transplant baseline (FEV1/FVC ratio <0.8)
- No evidence of acute infection
- ANC >1000
- Platelets >50,000
- Age 18-70
- ECOG performance Status 0-2.
Exclusion Criteria:
- Patient has a platelet count of less than 50,000 within 14 days before enrollment.
- Patient has an absolute neutrophil count of less 1000 within 14 days before enrollment.
- Patient has a calculated or measured creatinine clearance of < 20 ml/minute within 14 days before enrollment.
- Patient has Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Inability of give consent

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 | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Manu Jain, MD, MS | Northwestern University | |
Principal Investigator: | Jayesh Mehta, MD | Northwestern University |
Responsible Party: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT01163786 History of Changes |
Other Study ID Numbers: |
NU 09H7 NU 09H7 ( Other Identifier: Northwestern University Cancer Center ) STU00022160 ( Other Identifier: Northwestern University IRB ) |
First Posted: | July 16, 2010 Key Record Dates |
Last Update Posted: | January 11, 2018 |
Last Verified: | January 2018 |
Keywords provided by Northwestern University:
Bortezomib GVHD Bronchiolitis Obliterans |
Additional relevant MeSH terms:
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Bortezomib Antineoplastic Agents |