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

Acute Myeloblastic Leukemia Clinical Trial

— ALFA1200  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01966497
• Other study ID #: NI11020
• Status: Recruiting
• Phase: N/A
• First received: October 17, 2013
• Last updated: November 17, 2017
• Start date: November 2012
• Est. completion date: November 2019

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Hervé Dombret, MD PhD
• Phone: 33 1 4249 49 49
• Email: herve.dombret[@]sls.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloblastic Leukemia
• Aged Higher Than 60 Years Old
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
France	Avicenne	Bobigny	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative incidence of failures	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	9 months
Secondary	response rate		9 months
Secondary	relapse rate	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	within 2 years after inclusion
Secondary	overall survival		within 2 years after inclusion
Secondary	adverse events		within 2 years after inclusion