Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00260832




Registration number
NCT00260832
Ethics application status
Date submitted
1/12/2005
Date registered
2/12/2005
Date last updated
11/09/2019

Titles & IDs
Public title
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Scientific 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
Secondary ID [1] 0 0
DACO-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cytarabine or Supportive Care
Treatment: Drugs - Dacogen (decitabine) only

Experimental: 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.)

Active comparator: B -


Treatment: Drugs: 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.)

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
Timepoint [1] 0 0
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 [1] 0 0
Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp)
Timepoint [1] 0 0
Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
485
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- South Brisbane
Recruitment hospital [4] 0 0
- Adelaide
Recruitment hospital [5] 0 0
- East Melbourne
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Canada
State/province [20] 0 0
Newfoundland and Labrador
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Croatia
State/province [23] 0 0
Rijeka
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagreb
Country [25] 0 0
Croatia
State/province [25] 0 0
Zalaegerszeg
Country [26] 0 0
Czechia
State/province [26] 0 0
Brno
Country [27] 0 0
Czechia
State/province [27] 0 0
Ceske Budejovice
Country [28] 0 0
Czechia
State/province [28] 0 0
Plzen
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
France
State/province [30] 0 0
Bobigny
Country [31] 0 0
France
State/province [31] 0 0
Creteil Cedex
Country [32] 0 0
France
State/province [32] 0 0
Lille
Country [33] 0 0
France
State/province [33] 0 0
Limoges Cedex
Country [34] 0 0
France
State/province [34] 0 0
Lyon
Country [35] 0 0
France
State/province [35] 0 0
Nantes
Country [36] 0 0
France
State/province [36] 0 0
Pessac
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Gyor
Country [39] 0 0
Hungary
State/province [39] 0 0
Gyula
Country [40] 0 0
Hungary
State/province [40] 0 0
Szeged
Country [41] 0 0
Hungary
State/province [41] 0 0
Szombathely
Country [42] 0 0
Mexico
State/province [42] 0 0
Mexico City
Country [43] 0 0
Poland
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Lodz
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Poznan
Country [48] 0 0
Poland
State/province [48] 0 0
Warszawa
Country [49] 0 0
Poland
State/province [49] 0 0
Wroclaw
Country [50] 0 0
Romania
State/province [50] 0 0
Bucharest
Country [51] 0 0
Romania
State/province [51] 0 0
Cluj-Napoca
Country [52] 0 0
Romania
State/province [52] 0 0
Targu-Mures
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Arkhangelsk
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Astrakhan
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Barnaul
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Izhevsk
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Kirov
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Kransnodar
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Moscow
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Novosibirsk
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Petrozavodsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Ryazan
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Samara
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Saratov
Country [65] 0 0
Russian Federation
State/province [65] 0 0
St. Petersburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Tyumen
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Volgograd
Country [68] 0 0
Serbia
State/province [68] 0 0
Belgrade
Country [69] 0 0
Serbia
State/province [69] 0 0
Nis
Country [70] 0 0
Serbia
State/province [70] 0 0
Novi Sad
Country [71] 0 0
Spain
State/province [71] 0 0
Badalona-Barcelona
Country [72] 0 0
Spain
State/province [72] 0 0
Barcelona
Country [73] 0 0
Spain
State/province [73] 0 0
Girona
Country [74] 0 0
Spain
State/province [74] 0 0
Madrid
Country [75] 0 0
Spain
State/province [75] 0 0
Palma de Mallorca
Country [76] 0 0
Spain
State/province [76] 0 0
Pamplona
Country [77] 0 0
Spain
State/province [77] 0 0
Salamanca
Country [78] 0 0
Spain
State/province [78] 0 0
Valencia
Country [79] 0 0
Taiwan
State/province [79] 0 0
Changhua
Country [80] 0 0
Taiwan
State/province [80] 0 0
Kaohsiung
Country [81] 0 0
Taiwan
State/province [81] 0 0
Tainan
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taipei
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00260832
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Eisai Medical Services
Address 0 0
Eisai Global Clinical Development
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00260832