Overview
This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.
Eligibility
Inclusion Criteria:
- Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
- Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
- No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) < 50%
- Age ≥ 60 years and < 75 years
- ECOG performance status ≤2
- Written informed consent
- No psychological, familial, social, or geographic reason that would compromise clinical follow up
Exclusion Criteria:
- Relapsed or refractory AML
- Patients with acute promyelocytic leukemia (APL)
- Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
- Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
- Subjects for which allogeneic HSCT is planned in CR1
- Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
- Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications