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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00358644
First Posted: August 1, 2006
Last Update Posted: May 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  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
Intervention Model: Single Group Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00358644     History of Changes
Obsolete Identifiers: NCT00238095
Other Study ID Numbers: DACO-017
First Submitted: July 31, 2006
First Posted: August 1, 2006
Results First Submitted: April 13, 2009
Results First Posted: September 7, 2009
Last Update Posted: May 20, 2013
Last Verified: June 2010

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

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