Clinical trial NCT00260832: Trial of Decitabine in Patients With Acute Myeloid Leukemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Dacogen
Decitabine
Poor or intermediate-risk cytogenetics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 485
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Must not have acute promyelocytic leukemia (M3 classification)
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.

Primary outcomes:
measure: Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
timeFrame: 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:
measure: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
timeFrame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Highland Park
country: United States
state: Illinois
city: Terre Haute
country: United States
state: Indiana
city: Sioux City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Grosse Pointe Woods
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Neptune
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Eau Claire
country: United States
state: Wisconsin
city: Glendale
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Darlinghurst
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: South Brisbane
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: East Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: Toronto
country: Canada
state: Ontario
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Zalaegerszeg
country: Croatia
city: Brno
country: Czechia
city: Ceske Budejovice
country: Czechia
city: Plzen
country: Czechia
city: Praha 2
country: Czechia
city: Bobigny
country: France
city: Creteil Cedex
country: France
city: Lille
country: France
city: Limoges Cedex
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Pessac
country: France
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Szeged
country: Hungary
city: Szombathely
country: Hungary
city: Mexico City
country: Mexico
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Cluj-Napoca
country: Romania
city: Targu-Mures
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Astrakhan
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kirov
country: Russian Federation
city: Kransnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Belgrade
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Badalona-Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Sutton
country: United Kingdom
Study officials:
affiliation: Eisai Global Clinical Development
name: Eisai Medical Services
role: STUDY_DIRECTOR
References:
citation: 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.