Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia

Study Overview
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Brief Summary
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The main objective of this observational survey is to estimate the incidence, the typology, and the evolution of patients with acute myelobalstic leukemia, aged more than 60 years old. In this age group (aged more than 60y), three groups of patients with very different response rates and late outcome can be delineated with specific standard chemotherapy.

Official Title
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Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine

Conditions
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Acute Myeloblastic Leukemia, Aged Higher Than 60 Years Old

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 years or more With a morphologically proven diagnosis of AML according to WHO 2008 classification Not previously treated for AML Signed informed consent. Exclusion Criteria: APL in the WHO classification. Ph1-positive AML or prior Ph1-positive disease AML evolving from a prior MPN in the WHO 2008 classification. Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma ECOG Performance Status Score > 3 Positive serology for HIV or HTLV1, or active viralinfection for HBV and HBC. Severe uncontrolled infection at inclusion time. Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable. Absence of Health Care Insurance

Ages Eligible for Study
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Minimum Age: 60 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Core study therapy<br>idarubicin for both induction and consolidation courses if Cr, two cycles of IDAC alone (1.5g/m2 per infusion every 12hours, on D1, 3 and 5 of each cycle) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative incidence of failures | failures include resistant disease defined according to the IWG AML response criteria hypoplastic marrow after D42 and absence of myeloidrecovery early relapse up to 9 months from CR : Either AML relapse as in the IWG classification or MDS relapse | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | 9 months | 
| relapse rate | Either AML relapse as in the IWG classification - Or MDS relapse defined for this study as follows: (i) Persistent cytopenias, if unexplained by other cause, and (ii) myelodysplastic marrow with less than 20% marrow blasts in two samples taken 3 months apart | within 2 years after inclusion | 
| overall survival |  | within 2 years after inclusion | 
| adverse events |  | within 2 years after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML