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A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

Phase 2
Open (Enrolling)
Bronchiolitis Obliterans

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Trial Information

A Phase 2 Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

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not part of normal medical care, with the understanding that consent may be withdrawn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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in pulmonary function as measured by FEV1 from baseline and 9 weeks later.

Outcome Description:

Research subjects will receive 2 4 week cycles of bortezomib with a 1 week holiday between cycles.

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

Manu Jain, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 09H7



Start Date:

July 2010

Completion Date:

June 2015

Related Keywords:

  • Bronchiolitis Obliterans
  • Bortezomib GVHD Bronchiolitis Obliterans
  • Bronchiolitis
  • Bronchiolitis Obliterans



Northwestern UniversityChicago, Illinois  60611