Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Information source: University of Michigan Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Injury, Acute; Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans
Intervention: Etanercept (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Michigan Cancer Center
Official(s) and/or principal investigator(s):
Gregory A Yanik, MD, Principal Investigator, Affiliation: The University of Michigan Comprehensive Cancer Center
The purpose of this study is to determine the effectiveness of etanercept in the treatment of
patients with sub-acute lung injury following a bone marrow transplant. This study will also
examine the toxicity of treatment with etanercept as well as whether there is an improved
quality of life in these patients.
Official title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the response to etanercept therapy, based upon pulmonary function parameters (FEV1.0, FEV1.0/FVC, DLCO) in patients with sub-acute lung injury > 100 days post transplant
To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant.
To evaluate the effect of etanercept on BAL fluid and serum markers of pulmonary inflammation.
To examine health related quality of life parameters, including longitudinal changes in and magnitude of persistent disability in patients with sub-acute lung injury post transplant.
Lung or breathing problems can develop several months to years following a bone marrow
transplant. In some cases, these breathing problems develop without any signs of germs or
infection in the lungs. The name for this type of breathing problem is called "Sub-Acute
Lung Injury". Sub-acute lung injury often develops many months, even years following a bone
marrow transplant. It is often characterized by shortness of breath, cough, wheezing and
Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it
difficult to take deep breaths), or it can cause the lungs to get weak (making people feel
out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may
eventually die from the damage in their lungs. Typically, such patients die from infections
that develop inside the damaged lungs.
In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel).
The physicians feel there is the possibility that Etanercept may help improve breathing.
Breathing ability will be assessed prior to treatment as well as during and after treatment
so that comparisons can be made.
Minimum age: 6 Years.
Maximum age: N/A.
- Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell
transplants are eligible
- Age >6 years and able to complete pulmonary function testing
- Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or
- Recipients of sub-ablative transplant regimens are eligible
- Recipients of donor leukocyte infusions (DLI) post-transplant are eligible
- Patients must be > 100 days post transplant
- Patients with hypotension requiring inotropic agents other than dopamine < 5mcg/ kg/
minute for blood pressure support.
- Patients with a positive quantitative bacterial culture from the BAL fluid (≥ 104 CFU/
ml is considered positive)
- Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic
nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR
- Patients who are enrolled on a phase I or phase II trial for the prophylaxis or
treatment of GVHD (acute or chronic) within 7 days of study entry.
- Patients with known hypersensitivity to etanercept.
- Patients who are pregnant.
- Patients with CMV seropositivity at the time of study entry. Testing may include
wither CMV PCR analysis or CMV pp65 testing.
- Evidence for multi-system organ failure.
Locations and Contacts
The University of Michigan Cancer Center, Ann Arbor, Michigan 48109, United States
Starting date: October 2003
Ending date: December 2009
Last updated: June 4, 2008