Back to resultsStudy of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, AML, Decitabine, Dacogen, MGI PHARMA, INC.
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Complete Response = Morphologic Complete Remission (mCR)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358644
Brief Title
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Official Title
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia, AML, Decitabine, Dacogen, MGI PHARMA, INC.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Decitabine
Other Intervention Name(s)
Dacogen
Intervention Description
20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Complete Response = Morphologic Complete Remission (mCR)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eisai US Medical Services
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1678
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mgipharma.com
Description
Official website of MGI PHARMA, Inc.
Learn more about this trial
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
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