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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

Tracking Information
First Submitted Date October 17, 2013
First Posted Date October 21, 2013
Last Update Posted Date November 20, 2017
Actual Study Start Date November 2012
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2013)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01966497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 17, 2013)
  • response rate [ Time Frame: 9 months ]
  • 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
  • overall survival [ Time Frame: within 2 years after inclusion ]
  • adverse events [ Time Frame: within 2 years after inclusion ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia
Official Title Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population hospital admissions from the participating centres
Condition
  • Acute Myeloblastic Leukemia
  • Aged Higher Than 60 Years Old
Intervention Not Provided
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 17, 2017)
1000
Original Estimated Enrollment
 (submitted: October 17, 2013)
500
Estimated Study Completion Date November 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01966497
Other Study ID Numbers NI11020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2017