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

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.
 
ClinicalTrials.gov Identifier: NCT00358644
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : September 7, 2009
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Decitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
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
Study Start Date : March 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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.

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
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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
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Study Director: Eisai US Medical Services Eisai Inc.
Additional Information:
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00358644    
Obsolete Identifiers: NCT00238095
Other Study ID Numbers: DACO-017
First Posted: August 1, 2006    Key Record Dates
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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors