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Trial record 1 of 1 for:    NCT01966497
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Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)

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ClinicalTrials.gov Identifier: NCT01966497
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : October 21, 2013
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease
Acute Myeloblastic Leukemia Aged Higher Than 60 Years Old

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
Actual Study Start Date : November 2012
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. cumulative incidence of failures [ Time Frame: 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 :
  1. response rate [ Time Frame: 9 months ]
  2. relapse rate [ Time Frame: 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


  3. overall survival [ Time Frame: within 2 years after inclusion ]
  4. adverse events [ Time Frame: within 2 years after inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospital admissions from the participating centres
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966497


Contacts
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Contact: Hervé Dombret, MD PhD 33 1 4249 49 49 herve.dombret@sls.aphp.fr

Locations
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France
Avicenne Recruiting
Bobigny, Ile De France, France, 93
Contact: Claude Gardin, MD       claude.gardin@avc.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01966497    
Other Study ID Numbers: NI11020
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
AML
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms