Acute Myeloblastic Leukemia, Aged Higher Than 60 Years Old
Conditions
Keywords
AML
Brief summary
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative incidence of failures | 9 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 9 months | — |
| relapse rate | within 2 years after inclusion | 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 |
| overall survival | within 2 years after inclusion | — |
| adverse events | within 2 years after inclusion | — |
Countries
France
Contacts
Primary ContactHervé Dombret, MD PhD
Outcome results
None listed