Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Completed · Phase 2
Conditions studied: Lung Injury, Acute, Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans
In brief
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.
Key facts
- Study ID
- NCT00141726
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 34
- Starts
- 2003-10-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2015-12-03
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 RLD)
- 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
You may not qualify if…
- 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 analysis
- 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.
Where it is running
- The University of Michigan Cancer Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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