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Trial of Decitabine in Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00260832
Recruitment Status : Completed
First Posted : December 2, 2005
Results First Posted : September 21, 2011
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Cytarabine or Supportive Care Drug: Dacogen (decitabine) only Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
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.)
 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 intervention.)
Active Comparator: B 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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 :
  1. Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) [ Time Frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260832


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Eisai Medical Services Eisai Global Clinical Development
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00260832    
Other Study ID Numbers: DACO-016
First Posted: December 2, 2005    Key Record Dates
Results First Posted: September 21, 2011
Last Update Posted: September 11, 2019
Last Verified: September 2011
Keywords provided by Eisai Inc.:
Acute Myeloid Leukemia
Dacogen
Decitabine
Poor or intermediate-risk cytogenetics
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors