Acute Myeloid Leukemia Clinical Trial

Trial of Decitabine in Patients With Acute Myeloid Leukemia

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

485

Study ID:

NCT00260832

Recruitment Status:

Completed

Sponsor:

Eisai Inc.

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There are 53 Locations for this study

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Los Angeles California, , United States

Fort Myers Florida, 33901, United States

Gainesville Florida, 32610, United States

Hollywood Florida, , United States

Lakeland Florida, 33805, United States

Miami Florida, , United States

Orange Park Florida, 32073, United States

Chicago Illinois, 60612, United States

Highland Park Illinois, , United States

Terre Haute Indiana, 47804, United States

Sioux City Iowa, 51101, United States

Wichita Kansas, 67214, United States

Baton Rouge Louisiana, , United States

Shreveport Louisiana, , United States

Boston Massachusetts, , United States

Springfield Massachusetts, 01107, United States

Grosse Pointe Woods Michigan, 48236, United States

Kalamazoo Michigan, 49048, United States

Neptune New Jersey, , United States

New York New York, , United States

Valhalla New York, 10595, United States

Durham North Carolina, 27710, United States

Canton Ohio, 44710, United States

Cincinnati Ohio, 45267, United States

Pittsburgh Pennsylvania, 15232, United States

Charleston South Carolina, 29406, United States

Greenville South Carolina, , United States

Sioux Falls South Dakota, 57105, United States

Knoxville Tennessee, 37920, United States

Nashville Tennessee, , United States

Austin Texas, 78705, United States

Galveston Texas, 77555, United States

Houston Texas, 77030, United States

Temple Texas, , United States

Eau Claire Wisconsin, , United States

Glendale Wisconsin, 53212, United States

Milwaukee Wisconsin, , United States

Darlinghurst New South Wales, , Australia

St. Leonards New South Wales, 2065, Australia

South Brisbane Queensland, 4101, Australia

Adelaide South Australia, , Australia

East Melbourne Victoria, 3002, Australia

Parkville Victoria, 3052, Australia

Perth Western Australia, 6000, Australia

St. John's Newfoundland and Labrador, AiB 3, Canada

Halifax Nova Scotia, B3H 2, Canada

Toronto Ontario, M4N 3, Canada

Rijeka , , Croatia

Zagreb , , Croatia

Zalaegerszeg , , Croatia

Brno , 62500, Czechia

Ceske Budejovice , , Czechia

Plzen , , Czechia

Praha 2 , 128 0, Czechia

Bobigny , 93009, France

Creteil Cedex , , France

Lille , 59037, France

Limoges Cedex , , France

Lyon , 69437, France

Nantes , 44000, France

Pessac , , France

Budapest , , Hungary

Gyor , 9024, Hungary

Gyula , 5700, Hungary

Szeged , , Hungary

Szombathely , , Hungary

Mexico City , , Mexico

Gdansk , , Poland

Krakow , , Poland

Lodz , 93-51, Poland

Lublin , 20-08, Poland

Poznan , , Poland

Warszawa , , Poland

Wroclaw , 50-36, Poland

Bucharest , , Romania

Cluj-Napoca , 40012, Romania

Targu-Mures , 54004, Romania

Arkhangelsk , , Russian Federation

Astrakhan , , Russian Federation

Barnaul , , Russian Federation

Izhevsk , , Russian Federation

Kirov , , Russian Federation

Kransnodar , , Russian Federation

Moscow , , Russian Federation

Novosibirsk , , Russian Federation

Petrozavodsk , , Russian Federation

Ryazan , , Russian Federation

Samara , , Russian Federation

Saratov , , Russian Federation

St. Petersburg , , Russian Federation

Tyumen , , Russian Federation

Volgograd , , Russian Federation

Belgrade , 11000, Serbia

Nis , , Serbia

Novi Sad , 21000, Serbia

Badalona-Barcelona , 08916, Spain

Barcelona , 08035, Spain

Girona , , Spain

Madrid , 28006, Spain

Palma de Mallorca , 07014, Spain

Pamplona , 31008, Spain

Salamanca , , Spain

Valencia , , Spain

Changhua , , Taiwan

Kaohsiung , , Taiwan

Tainan , 70403, Taiwan

Taipei , 10449, Taiwan

Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

485

Study ID:

NCT00260832

Recruitment Status:

Completed

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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