Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
week 12 post therapy
Gregory A Yanik, MD
The University of Michigan Comprehensive Cancer Center
United States: Food and Drug Administration
|The University of Michigan Cancer Center||Ann Arbor, Michigan 48109|