Trial of Decitabine in Patients With Acute Myeloid Leukemia
NCT ID: NCT00260832
Last Updated: 2019-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
485 participants
INTERVENTIONAL
2005-11-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.)
Cytarabine or Supportive Care
Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
B
Dacogen (decitabine) only
20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
Interventions
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Cytarabine or Supportive Care
Patient's choice with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m\^2 subcutaneously once daily for the first 10 consecutive days of each 28 day cycle, until progression or unacceptable toxicity develops. (These represent one intervention.)
Dacogen (decitabine) only
20mg/m\^2, 1 hour intravenous (IV) for 5 consecutive days of each 28 day cycle. Cycles continue until disease progression or unacceptable toxicity develops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have a life expectancy of at least 12 weeks.
3. Must sign informed consent.
Exclusion Criteria
2. Must not have any other active systemic malignancies.
3. Must not have inaspirable bone marrow.
4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
5. Must not have chronic respiratory disease that requires continuous oxygen use.
6. Must not have received any experimental drug within 4 weeks before randomization.
7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
8. Must not have known HIV.
65 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai Medical Services
Role: STUDY_DIRECTOR
Eisai Global Clinical Development
Locations
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Los Angeles, California, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Orange Park, Florida, United States
Chicago, Illinois, United States
Highland Park, Illinois, United States
Terre Haute, Indiana, United States
Sioux City, Iowa, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Grosse Pointe Woods, Michigan, United States
Kalamazoo, Michigan, United States
Neptune City, New Jersey, United States
New York, New York, United States
Valhalla, New York, United States
Durham, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Sioux Falls, South Dakota, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Temple, Texas, United States
Eau Claire, Wisconsin, United States
Glendale, Wisconsin, United States
Milwaukee, Wisconsin, United States
Darlinghurst, New South Wales, Australia
St Leonards, New South Wales, Australia
South Brisbane, Queensland, Australia
Adelaide, South Australia, Australia
East Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Perth, Western Australia, Australia
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Rijeka, , Croatia
Zagreb, , Croatia
Zalaegerszeg, , Croatia
Brno, , Czechia
České Budějovice, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Bobigny, , France
Créteil, , France
Lille, , France
Limoges, , France
Lyon, , France
Nantes, , France
Pessac, , France
Budapest, , Hungary
Győr, , Hungary
Gyula, , Hungary
Szeged, , Hungary
Szombathely, , Hungary
Mexico City, , Mexico
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Târgu Mureş, , Romania
Arkhangelsk, , Russia
Astrakhan, , Russia
Barnaul, , Russia
Izhevsk, , Russia
Kirov, , Russia
Kransnodar, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Petrozavodsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Tyumen, , Russia
Volgograd, , Russia
Belgrade, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Badalona-Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Palma de Mallorca, , Spain
Pamplona, , Spain
Salamanca, , Spain
Valencia, , Spain
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Sutton, , United Kingdom
Countries
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References
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Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.
Other Identifiers
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DACO-016
Identifier Type: -
Identifier Source: org_study_id
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