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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 relapse of the disease.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Eisai Inc.
• Treatments: Azacitidine; Decitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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