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

NCT01966497 | Unknown

• 1 other identifier: NI11020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloblastic Leukemia; Aged Higher Than 60 Years Old

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• response rate

  9 months

• relapse rate

  within 2 years after inclusion

• overall survival

  within 2 years after inclusion

• adverse events

  within 2 years after inclusion

Study Arms (1)

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)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital admissions from the participating centres

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Psychiatric disease or an history of non-complianceto medical regimens or patients considered potentially unreliable.
• Absence of Health Care Insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Avicenne

Bobigny, Île-de-France Region, 93, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32380535 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Hervé Dombret, MD PhD

CONTACT

33 1 4249 49 49; herve.dombret@sls.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 21, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

FR (1)