Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)
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ClinicalTrials.gov Identifier: NCT01966497
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique - Hôpitaux de Paris. Recruitment status was: Recruiting
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.
Condition or disease
Acute Myeloblastic LeukemiaAged Higher Than 60 Years Old
cumulative incidence of failures [ Time Frame: 9 months ]
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 Outcome Measures :
response rate [ Time Frame: 9 months ]
relapse rate [ Time Frame: 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 [ Time Frame: within 2 years after inclusion ]
adverse events [ Time Frame: within 2 years after inclusion ]
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Layout table for eligibility information
Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
hospital admissions from the participating centres
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.
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.