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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Eisai Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Global Clinical Development

Authority:

United States: Food and Drug Administration

Study ID:

DACO-016

NCT ID:

NCT00260832

Start Date:

November 2005

Completion Date:

December 2010

Related Keywords:

• Acute Myeloid Leukemia
• Acute Myeloid Leukemia
• Dacogen
• Decitabine
• Poor or intermediate-risk cytogenetics
• Leukemia
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid