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OpenTrials
Completed

NCT Number: NCT00358644

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

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).

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duarte, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

decitabine

Drug

20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.

Other names: Dacogen

Primary outcomes

  1. Complete Response = Morphologic Complete Remission (mCR)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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