Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms

Inclusion Criteria:

1. Age 61 years or more

2. Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.

3. Absence of central nervous system involvement

4. No contraindications for intensive chemotherapy, defined as:

   1. prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
   2. a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
   3. a Performance Status (PS) score of > 2;
   4. uncontrolled severe infection.

5. Informed consent.

Exclusion Criteria:

1. Age ≤ 60 years
2. Newly diagnosed AML with < 30% myeloid marrow blasts
3. Previously treated AML
4. Central nervous system involvement
5. Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
6. A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
7. A PS score of > 2;
8. Uncontrolled severe infection.