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

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. Identifier:
First received: July 31, 2006
Last updated: May 13, 2013
Last verified: June 2010
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).

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Decitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Complete Response = Morphologic Complete Remission (mCR) [ Time Frame: 1 year ]

Enrollment: 55
Study Start Date: March 2005
Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Decitabine
20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
Other Name: Dacogen


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Received previous treatment for AML.
  2. Previously received Vidaza.
  3. Received any other investigational agents within 30 days of first dose of study drug.
  4. Uncontrolled intercurrent illness.
  5. Had radiotherapy within 14 days prior to study enrollment.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00358644

United States, California
Duarte, California, United States, 91010
Los Angeles, California, United States, 90095-1678
United States, Missouri
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Eisai Inc.
Study Director: Eisai US Medical Services Eisai Inc.
  More Information

Additional Information:
Responsible Party: Eisai Inc. Identifier: NCT00358644     History of Changes
Obsolete Identifiers: NCT00238095
Other Study ID Numbers: DACO-017
Study First Received: July 31, 2006
Results First Received: April 13, 2009
Last Updated: May 13, 2013

Keywords provided by Eisai Inc.:
Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors processed this record on August 16, 2017