To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

Stopped early · Phase 4

Conditions studied: Myelodysplastic Syndromes

In brief

The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.

Key facts

Study ID

NCT01011283

Run by

Eisai Inc.

People needed

26

Starts

2009-11-01

Last updated by the study team

2014-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who meet all of the following criteria may be included in the study:
• Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk [defined by International Prognostic Scoring System (IPSS) score of ≥0.5] and recognized French-American-British (FAB) classifications
• Male or female, 18 years of age or older with signed informed consent
• Adequate renal function
• Demonstrated normal liver function
• Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
• Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.

You may not qualify if…

• Subjects who meet any of the following criteria will be excluded from participation in the study:
• Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if > 2 weeks from study entry and if recovered from toxic effects of therapy)
• Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
• Pregnancy or current lactation
• Significant concurrent disease, illness, or psychiatric disorder
• Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine

Where it is running

• Birmingham Hematology and Oncology Associates — Birmingham, Alabama, United States
• Stanford University Cancer Center — Stanford, California, United States
• Stockton Hematology Oncology — Stockton, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Pasco Pinellas Cancer Center — New Port Richey, Florida, United States
• Gulf Coast Oncology — St. Petersburg, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Siouxland Haeatology - Oncology Associates — Sioux City, Iowa, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Sletten Cancer Institute — Great Falls, Montana, United States
• Cornell Medical Center — New York, New York, United States
• Carolinas Medical Center NorthEast NorthEast Oncology Associates — Concord, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Oncology and Hematology Care — Cincinnati, Ohio, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Charleston Hematology Oncology Associates — Charleston, South Carolina, United States
• Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Gunderson Clinic Ltd. — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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