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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00358644
First received: July 31, 2006
Last updated: May 13, 2013
Last verified: June 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Decitabine
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Complete Response = Morphologic Complete Remission (mCR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358644

Locations
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.
Investigators
Study Director: Eisai US Medical Services Eisai Inc.
  More Information

Additional Information:
Official website of MGI PHARMA, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Acute Myeloid Leukemia
AML
Decitabine
Dacogen
MGI PHARMA, INC.

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013