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Trial of Decitabine in Patients With Acute Myeloid Leukemia

NCT00260832 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 485

Last updated 2019-09-11

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Eisai Medical Services · Eisai Global Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-10-31
Completion
2010-12-31

Countries

  • United States
  • Australia
  • Canada
  • Croatia
  • Czechia
  • France
  • Hungary
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260832 on ClinicalTrials.gov