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

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

• Registration Number: NCT01966497
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-21
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20
• Primary Completion: 2019-04
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
adverse events	within 2 years after inclusion
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

Trial Locations

Locations (1)

Avicenne; 🇫🇷 Bobigny, Ile De France, France