Status:
COMPLETED
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Lead Sponsor:
Eisai Inc.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice wi...
Eligibility Criteria
Inclusion
- Must have diagnosed acute myeloid leukemia.
- Must have a life expectancy of at least 12 weeks.
- Must sign informed consent.
Exclusion
- Must not have acute promyelocytic leukemia (M3 classification)
- Must not have any other active systemic malignancies.
- Must not have inaspirable bone marrow.
- Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
- Must not have chronic respiratory disease that requires continuous oxygen use.
- Must not have received any experimental drug within 4 weeks before randomization.
- Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
- Must not have known HIV.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00260832
Start Date
November 1 2005
End Date
December 1 2010
Last Update
September 11 2019
Active Locations (108)
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1
Los Angeles, California, United States
2
Fort Myers, Florida, United States, 33901
3
Gainesville, Florida, United States, 32610
4
Hollywood, Florida, United States