Trial of Decitabine in Patients With Acute Myeloid Leukemia

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Key facts

Study ID

NCT00260832

Run by

Eisai Inc.

People needed

485

Starts

2005-11-01

Expected to finish

2010-12-01

Last updated by the study team

2019-09-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have diagnosed acute myeloid leukemia.
• Must have a life expectancy of at least 12 weeks.
• Must sign informed consent.

You may not qualify if…

• Must not have acute promyelocytic leukemia (M3 classification)
• Must not have any other active systemic malignancies.
• Must not have inaspirable bone marrow.
• Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
• Must not have chronic respiratory disease that requires continuous oxygen use.
• Must not have received any experimental drug within 4 weeks before randomization.
• Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
• Must not have known HIV.

Where it is running

• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orange Park, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Highland Park, Illinois, United States
• Study site — Terre Haute, Indiana, United States
• Study site — Sioux City, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Grosse Pointe Woods, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Neptune City, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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