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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Hervé Dombret, MD PhD; Phone Number: 33 1 4249 49 49; Email: herve.dombret@sls.aphp.fr

Study Locations

• France
  • Ile De France
    • Bobigny, Ile De France, France, 93
      • Recruiting
      • Avicenne
      • Contact: Claude Gardin, MD; Email: claude.gardin@avc.aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital admissions from the participating centres

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Core study therapy; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival		within 2 years after inclusion
response rate		9 months
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
adverse events		within 2 years after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Gardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Ades L, Marolleau JP, Malfuson JV, Gastaud L, Raffoux E, Lambert J, Braun T, Thomas X, Chantepie S, Cluzeau T, de Botton S, Berthon C, Boissel N, Duployez N, Terre C, Peffault de Latour R, Michallet M, Celli-Lebras K, Preudhomme C, Dombret H. Added prognostic value of secondary AML-like gene mutations in ELN intermediate-risk older AML: ALFA-1200 study results. Blood Adv. 2020 May 12;4(9):1942-1949. doi: 10.1182/bloodadvances.2019001349.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: AML
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: NI11020