A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
NCT ID: NCT00260065
Last Updated: 2013-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2005-05-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Decitabine
20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Interventions
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Decitabine
20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must be 18 years of age or older.
3. Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.
Exclusion Criteria
2. Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
3. Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
4. Must not have an active viral or bacterial infection.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai US Medical Services
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Boca Raton, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Griffin, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Rochester, Minnesota, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
Canton, Ohio, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Midland, Texas, United States
Seattle, Washington, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Toronto, Ontario, Canada
Countries
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References
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Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.
Related Links
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MGI Pharma's website
Other Identifiers
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DACO-020
Identifier Type: -
Identifier Source: org_study_id
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