Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Acute Myeloblastic Leukemia; Aged Higher Than 60 Years Old

Study type: Observational

Funder types: Other

Identifiers

NCT01966497

NI11020

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Core study therapy

Description:

* 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)