Back to resultsTrial of Decitabine in Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cytarabine or Supportive Care
Dacogen (decitabine) only
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Dacogen, Decitabine, Poor or intermediate-risk cytogenetics
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
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.)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00260832
Brief Title
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
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, Dacogen, Decitabine, Poor or intermediate-risk cytogenetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
485 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.)
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cytarabine or Supportive Care
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
Dacogen (decitabine) only
Other Intervention Name(s)
decitabine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Description
Morphologic CR plus CRp rate where Morphologic leukemia-free state defined as less that (<) 5 percent (%) blasts in an aspirate sample with marrow spicules and a count of greater than or equal to (>=) 200 nucleated cells (there should have been no blasts with Auer rods or persistence of extramedullary disease) plus absolute neutrophil count (ANC) greater than (>)1,000 per microliter (/mcL), platelet count of >=100,000/mcL, and the participant must have been independent of transfusions for at least 1 week before each assessment. There was no duration requirement for confirmation of this designation and Morphologic CR without the requirement of platelet count >=100,000/mcL.
Time Frame
Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eisai Medical Services
Organizational Affiliation
Eisai Global Clinical Development
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Hollywood
State/Province
Florida
Country
United States
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Highland Park
State/Province
Illinois
Country
United States
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Temple
State/Province
Texas
Country
United States
City
Eau Claire
State/Province
Wisconsin
Country
United States
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Darlinghurst
State/Province
New South Wales
Country
Australia
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
City
Adelaide
State/Province
South Australia
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
AiB 3V6
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Rijeka
Country
Croatia
City
Zagreb
Country
Croatia
City
Zalaegerszeg
Country
Croatia
City
Brno
ZIP/Postal Code
62500
Country
Czechia
City
Ceske Budejovice
Country
Czechia
City
Plzen
Country
Czechia
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Creteil Cedex
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Limoges Cedex
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Nantes
ZIP/Postal Code
44000
Country
France
City
Pessac
Country
France
City
Budapest
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
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
ZIP/Postal Code
93-510
Country
Poland
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
City
Poznan
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
City
Bucharest
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
City
Targu-Mures
ZIP/Postal Code
540042
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
ZIP/Postal Code
11000
Country
Serbia
City
Nis
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Badalona-Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Girona
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Salamanca
Country
Spain
City
Valencia
Country
Spain
City
Changhua
Country
Taiwan
City
Kaohsiung
Country
Taiwan
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24498872
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.
Results Reference
derived
Learn more about this trial
Trial of Decitabine in Patients With Acute Myeloid Leukemia
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