Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
1 other identifier
interventional
55
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2005
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 31, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
September 7, 2009
CompletedMay 20, 2013
June 1, 2010
2.9 years
July 31, 2006
April 13, 2009
May 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response = Morphologic Complete Remission (mCR)
1 year
Study Arms (1)
1
EXPERIMENTALInterventions
20 mg/m\^2, IV on days 1-5 of each 28 day cycle; until death, progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (3)
Unknown Facility
Duarte, California, 91010, United States
Unknown Facility
Los Angeles, California, 90095-1678, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Call Center
- Organization
- Eisai Inc.
Study Officials
- STUDY DIRECTOR
Eisai US Medical Services
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2006
First Posted
August 1, 2006
Study Start
March 1, 2005
Primary Completion
February 1, 2008
Study Completion
December 1, 2008
Last Updated
May 20, 2013
Results First Posted
September 7, 2009
Record last verified: 2010-06