Status:
TERMINATED
A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Conditions:
Bronchiolitis Obliterans
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
- 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
Key Trial Info
Start Date :
October 7 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01163786
Start Date
October 7 2010
End Date
September 9 2015
Last Update
April 10 2020
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611