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

Assistance Publique - Hôpitaux de Paris1 site in 1 country1,000 target enrollmentNovember 2012

ConditionsAcute Myeloblastic Leukemia Aged Higher Than 60 Years Old

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myeloblastic Leukemia
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 1000
Locations: 1
Primary Endpoint: cumulative incidence of failures
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

November 2019

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

cumulative incidence of failures

Time Frame: 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