Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)

Completed · Phase 2/Phase 3

Conditions studied: Acute Myelogenous Leukemia

In brief

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 relapse of the disease.

Key facts

Study ID

NCT00398983

Run by

M.D. Anderson Cancer Center

People needed

50

Starts

2006-08-01

Expected to finish

2012-05-01

Last updated by the study team

2013-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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