Status:
COMPLETED
Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent...
Detailed Description
Methylation is a change that occurs to DNA that has an effect on how genes are used in human cells. It is very common in leukemias for methylation to happen abnormally. Decitabine is a new drug that b...
Eligibility Criteria
Inclusion
- Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp)
- Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp)
- Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
- Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
- Performance status of 0, 1, or 2
- Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal
Exclusion
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
- Known to be HIV+
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00398983
Start Date
August 1 2006
End Date
May 1 2012
Last Update
March 4 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030