Trial of Decitabine in Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00260832
First received: December 1, 2005
Last updated: September 20, 2011
Last verified: September 2011
Results First Received: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myeloid Leukemia
Interventions: Drug: Cytarabine or Supportive Care
Drug: Dacogen (decitabine) only

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 65 centers in 12 countries during the period of 2006 to 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, subjects indicated their preference for treatment, with physician's advice, or either cytarabine or supportive care in the event they were randomized to Arm A.

Reporting Groups
  Description
Cytarabine or Supportive Care Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
Dacogen (Decitabine) Only 20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.

Participant Flow:   Overall Study
    Cytarabine or Supportive Care     Dacogen (Decitabine) Only  
STARTED     243     242  
COMPLETED     15 [1]   31 [1]
NOT COMPLETED     228     211  
Adverse Event                 26                 19  
Progression                 116                 96  
Withdrawal by Subject                 15                 17  
Physician Decision                 15                 9  
Death                 43                 62  
Not Specified                 10                 7  
Protocol Violation                 3                 1  
[1] At study completion, these subjects chose to remain on treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cytarabine or Supportive Care Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
Dacogen (Decitabine) Only 20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Cytarabine or Supportive Care     Dacogen (Decitabine) Only     Total  
Number of Participants  
[units: participants]
  243     242     485  
Age  
[units: years]
Mean ± Standard Deviation
  73.53  ± 5.67     73.14  ± 5.24     73.34  ± 5.46  
Gender  
[units: participants]
     
Female     92     105     197  
Male     151     137     288  
Race (NIH/OMB)  
[units: Subjects]
     
American Indian or Alaska Native     0     0     0  
Asian     27     33     60  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     0     3  
White     213     209     422  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures

1.  Primary:   Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.   [ 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. ]

2.  Secondary:   Comparison of Complete Remission Rates Between Arm A and Arm B   [ Time Frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available. No stated duration of response required for complete remission classification ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Peter Tarassoff, MD, PhD, Study Director
Organization: Eisai Inc.
phone: 201-949-4611
e-mail: Peter_Tarasoff@eisai.com


No publications provided


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00260832     History of Changes
Other Study ID Numbers: DACO-016
Study First Received: December 1, 2005
Results First Received: April 13, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration