Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
I. Determine the frequency of hematologic responses in patients with MDS to 5-aza
(azacitidine) plus etanercept.
II. Determine the efficacy of 5-aza combined with etanercept in patients with low or
intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus
etanercept and for the purpose of this trial are considered as having progressive or "more
III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional
disease characteristics with in vivo treatment responses, to identify parameters that are
associated with a high probability of response.
Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and
azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every
28 days for at least 3 courses. Treatment continues in the absence of disease progression or
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of hematologic responses, as defined by International Working Group (IWG) criteria
A two-stage Simon design for phase II trials will be followed. The operating characteristics of this design yield a 90% chance of declaring a treatment ineffective if they true response rate is 0.30. If the true response rate is 0.50, there is an 80% chance of reaching the threshold of 13 responses out of 32 patients.
Up to 2 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
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