Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone

Conditions
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AML in Remission

Intervention / Treatment
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* Drug: Idarubicin
* Drug: ID cytarabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDA with ID Cytarabine<br> | Drug: Idarubicin<br>* Idarubicin 10mg/m²/day, D1 (IV)<br>Drug: ID cytarabine<br>* Cytarabine 1.5g/m² /12h, D1-D3 (IV)<br>|
| Active Comparator: ID Cytarabine<br> | Drug: ID cytarabine<br>* Cytarabine 1.5g/m² /12h, D1-D3 (IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse free survival | RFS | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities | Number and CTC grade of all adverse events related to study treatment analyzed in an descriptive way | enitire study course until 2 years | 
| Minimum Residual Disease | Immunophenotypic characterization of human bone marrow cells will be done to determine MRD | 6, 9, 12,18 and 24 months | 
| Overall survival | OS | 2 years |