NCT00260832

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.)
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.

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-10-01
• Completion: 2010-12-01
• First posted: 2005-12-02
• Last updated: 2019-09-11
• Results posted: 2011-09-21

Locations

108 sites across 15 countries: United States, Australia, Canada, Croatia, Czechia, France, Hungary, Mexico, Poland, Romania, Russia, Serbia, Spain, Taiwan, United Kingdom