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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2019-11-30

Brief Summary

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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

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Conditions

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Acute Myeloblastic Leukemia Aged Higher Than 60 Years Old

Keywords

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AML

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Avicenne

Bobigny, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hervé Dombret, MD PhD

Role: CONTACT

Phone: 33 1 4249 49 49

Email: [email protected]

Facility Contacts

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Claude Gardin, MD

Role: primary

References

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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.

Reference Type DERIVED

PMID: 32380535 (View on PubMed)

Other Identifiers

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NI11020

Identifier Type: -

Identifier Source: org_study_id