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History of Changes for Study: NCT01966497
Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)
Latest version (submitted November 17, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 17, 2013 None (earliest Version on record)
2 April 22, 2014 Study Status
3 April 20, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 November 17, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01966497
Submitted Date:  October 17, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: NI11020
Brief Title: Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)
Official Title: Observational Study of Patients Older Than 60 Years and With Acute Myeloblastic Leukemia Who Are Administered Standard Chemotherapy Based on Idarubicine-cytarabine
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2013
Overall Status: Recruiting
Study Start: November 2012
Primary Completion: November 2016 [Anticipated]
Study Completion: November 2018 [Anticipated]
First Submitted: October 17, 2013
First Submitted that
Met QC Criteria:
October 17, 2013
First Posted: October 21, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 17, 2013
Last Update Posted: October 21, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Assistance Publique - Hôpitaux de Paris
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Acute Myeloblastic Leukemia
Aged Higher Than 60 Years Old
Keywords: AML
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 500 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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)
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Study Population: hospital admissions from the participating centres
Sampling Method: Non-Probability Sample
Minimum Age: 60 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Hervé Dombret, MD PhD
Telephone: 33 1 4249 49 49
Email: herve.dombret@sls.aphp.fr
Locations: France, Ile de France
Avicenne
[Recruiting]
Bobigny, Ile de France, France, 93
Contact:Contact: Claude Gardin, MD claude.gardin@avc.aphp.fr
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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