Status:

COMPLETED

Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

Lead Sponsor:

Eisai Inc.

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

60+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

Eligibility Criteria

Inclusion

  • A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
  • Ineligible to receive intensive chemotherapy for their disease.
  • Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion

  • Received previous treatment for AML.
  • Previously received Vidaza.
  • Received any other investigational agents within 30 days of first dose of study drug.
  • Uncontrolled intercurrent illness.
  • Had radiotherapy within 14 days prior to study enrollment.

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00358644

Start Date

March 1 2005

End Date

December 1 2008

Last Update

May 20 2013

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Duarte, California, United States, 91010

2

Los Angeles, California, United States, 90095-1678

3

St Louis, Missouri, United States, 63110