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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
History of Changes

December 1, 2005
September 20, 2011
November 2005
October 2009   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
Overall survival in patients 65 years or older who have newly diagnosed de novo or secondary AML.
Complete list of historical versions of study NCT00260832 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Morphologic complete remission (CR) plus CR without platelet recovery (CRp) rate
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: 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 invervention.)
  • Drug: 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.
    Other Name: decitabine
  • 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.)
    Intervention: Drug: Cytarabine or Supportive Care
  • Active Comparator: B
    Intervention: Drug: Dacogen (decitabine) only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
485
December 2010
October 2009   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Croatia,   Czech Republic,   France,   Hungary,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   Taiwan,   United Kingdom
 
NCT00260832
DACO-016
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai Medical Services Eisai Global Clinical Development
Eisai Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP