Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an
important treatment option for a number of malignant and non-malignant disorders.
Unfortunately, pulmonary dysfunction remains a frequent and severe complication of
allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor
(TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients
will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to
treatment with etanercept to check for infection. If no infection is evident after 24 hours,
the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous
injection. There will be weekly blood tests and bronchoscopy after the last drug dose.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Kenneth Cooke, M.D.
University of Michigan, Ann Arbor, MI
United States: Food and Drug Administration
|University of Michigan||Ann Arbor, Michigan 48109-0624|