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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
485
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.)
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.
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.
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.
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.
Time frame: Post randomization when at least one post-baseline bone marrow assessment or peripheral blood count data available (up to 29.5 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Los Angeles, California, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Orange Park, Florida, United States
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Chicago, Illinois, United States
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Highland Park, Illinois, United States
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Terre Haute, Indiana, United States
...and 98 more locations