Secondary Acute Myeloid Leukemia Clinical Trial
Official title:
Soluble Tumor Necrosis Factor Receptor: Enbrel® (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
This phase II trial is studying how well etanercept works in treating young patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant. Etanercept may be effective in treating patients with idiopathic pneumonia syndrome after undergoing a donor stem cell transplant.
PRIMARY OBJECTIVES:
I. Determine the response rate, defined as survival and complete discontinuation of
supplemental oxygen at day 28, in pediatric patients with acute noninfectious pulmonary
dysfunction (idiopathic pneumonia syndrome [IPS]) after undergoing allogeneic stem cell
transplantation treated with etanercept.
SECONDARY OBJECTIVES:
I. Estimate the day 56 survival rate in patients treated with this drug. II. Determine the
overall survival distribution in patients treated with this drug.
III. Determine the pulmonary response, as defined as the time to discontinuation of
supplemental oxygen, in patients treated with this drug.
IV. Evaluate the toxicity of etanercept therapy in patients with IPS. V. Evaluate levels of
pro-inflammatory cytokines, in both bronchoalveolar lavage (BAL) fluid and serum, in patients
with IPS.
VI. Describe C-reactive protein (CRP) levels at baseline, day 7, 14, 21, and 28 and their
association with response in patients with IPS.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive etanercept IV over 30 minutes on day 0 and subcutaneously on days 3, 7, 10,
14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease
progression, or unacceptable toxicity. Patients also receive methylprednisolone (or
corticosteroid equivalent) IV on days 0-2 and then orally with a taper until day 56.
After completion of study treatment, patients are followed periodically for 5 years.
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