Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT00118287|
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes||Drug: azacitidine Biological: etanercept||Phase 1 Phase 2|
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 advanced" disease.
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 unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||October 2008|
Experimental: Treatment (chemotherapy, chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or 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 unacceptable toxicity.
Given SC or IV
- Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria [ Time Frame: Up to 2 years ]Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118287
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Bart Scott||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|