Trial of Decitabine in Patients With Acute Myeloid Leukemia
Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
1 other identifier
interventional
485
15 countries
108
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2005
Longer than P75 for phase_3
108 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 1, 2005
CompletedFirst Posted
Study publicly available on registry
December 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
September 21, 2011
CompletedSeptember 11, 2019
September 1, 2011
3.9 years
December 1, 2005
April 13, 2011
August 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Secondary Outcomes (1)
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
Study Arms (2)
A
EXPERIMENTALSubject'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.)
B
ACTIVE COMPARATORInterventions
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.)
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (108)
Unknown Facility
Los Angeles, California, United States
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Fort Myers, Florida, 33901, United States
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Gainesville, Florida, 32610, United States
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Hollywood, Florida, United States
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Lakeland, Florida, 33805, United States
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Miami, Florida, United States
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Orange Park, Florida, 32073, United States
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Chicago, Illinois, 60612, United States
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Highland Park, Illinois, United States
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Terre Haute, Indiana, 47804, United States
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Sioux City, Iowa, 51101, United States
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Wichita, Kansas, 67214, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, 01107, United States
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Grosse Pointe Woods, Michigan, 48236, United States
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Kalamazoo, Michigan, 49048, United States
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Neptune City, New Jersey, United States
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New York, New York, United States
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Valhalla, New York, 10595, United States
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Durham, North Carolina, 27710, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45267, United States
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Pittsburgh, Pennsylvania, 15232, United States
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Charleston, South Carolina, 29406, United States
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Greenville, South Carolina, United States
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Sioux Falls, South Dakota, 57105, United States
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Knoxville, Tennessee, 37920, United States
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Nashville, Tennessee, United States
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Austin, Texas, 78705, United States
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Galveston, Texas, 77555, United States
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Houston, Texas, 77030, United States
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Temple, Texas, United States
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Eau Claire, Wisconsin, United States
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Glendale, Wisconsin, 53212, United States
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Milwaukee, Wisconsin, United States
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Darlinghurst, New South Wales, Australia
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St Leonards, New South Wales, 2065, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, Australia
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East Melbourne, Victoria, 3002, Australia
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Parkville, Victoria, 3052, Australia
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Perth, Western Australia, 6000, Australia
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St. John's, Newfoundland and Labrador, AiB 3V6, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Rijeka, Croatia
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Zagreb, Croatia
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Zalaegerszeg, Croatia
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Brno, 62500, Czechia
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České Budějovice, Czechia
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Pilsen, Czechia
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Prague, 128 08, Czechia
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Bobigny, 93009, France
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Créteil, France
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Lille, 59037, France
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Limoges, France
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Lyon, 69437, France
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Nantes, 44000, France
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Pessac, France
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Budapest, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Szeged, Hungary
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Szombathely, Hungary
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Mexico City, Mexico
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Gdansk, Poland
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Krakow, Poland
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Lodz, 93-510, Poland
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Lublin, 20-081, Poland
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Poznan, Poland
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Warsaw, Poland
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Wroclaw, 50-367, Poland
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Bucharest, Romania
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Cluj-Napoca, 400124, Romania
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Târgu Mureş, 540042, Romania
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Arkhangelsk, Russia
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Astrakhan, Russia
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Barnaul, Russia
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Izhevsk, Russia
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Kirov, Russia
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Kransnodar, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Petrozavodsk, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tyumen, Russia
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Volgograd, Russia
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Belgrade, 11000, Serbia
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Niš, Serbia
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Novi Sad, 21000, Serbia
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Badalona-Barcelona, 08916, Spain
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Barcelona, 08035, Spain
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Girona, Spain
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Madrid, 28006, Spain
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Palma de Mallorca, 07014, Spain
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Pamplona, 31008, Spain
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Salamanca, Spain
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Valencia, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10449, Taiwan
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Sutton, United Kingdom
Related Publications (1)
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.
PMID: 24498872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Study Officials
- STUDY DIRECTOR
Eisai Medical Services
Eisai Global Clinical Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2005
First Posted
December 2, 2005
Study Start
November 1, 2005
Primary Completion
October 1, 2009
Study Completion
December 1, 2010
Last Updated
September 11, 2019
Results First Posted
September 21, 2011
Record last verified: 2011-09