Trial of Decitabine in Patients With Acute Myeloid Leukemia
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00260832|
Recruitment Status : Completed
First Posted : December 2, 2005
Results First Posted : September 21, 2011
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Cytarabine or Supportive Care Drug: Dacogen (decitabine) only||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||485 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Study Director:||Eisai Medical Services||Eisai Global Clinical Development|