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Sponsored by: |
Eisai Inc. |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00358644 |
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 II |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic |
Drug Information available for: | 5-Aza-2'-deoxycytidine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Decitabine For the Front-Line Treatment of Older Patients With Acute Myeloid Leukemia |
Enrollment: | 55 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Decitabine
20 mg/m^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
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(Note: This clinical trial was quality controlled by itself, since no protocol was available to Eisai Medical Research Inc.)
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
City of Hope National Medical Center | |||||
Duarte, California, United States, 91010 | |||||
UCLA Division of Hematology/Oncology | |||||
Los Angeles, California, United States, 90095-1678 | |||||
United States, Missouri | |||||
Washington University School of Medicine | |||||
St. Louis, Missouri, United States, 63110 |
Eisai Inc. |
Study Director: | Akhil Baranwal, MD | Eisai Medical Research Inc. |
Official website of MGI PHARMA, Inc. 
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Responsible Party: | Eisai Inc. ( Eisai Medical Services ) |
Study ID Numbers: | DACO-017 |
First Received: | July 31, 2006 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00358644 |
Health Authority: | United States: Food and Drug Administration |
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