Observational Study of Patients Older Than 60 Years With Acute Myeloblastic Leukemia (ALFA1200)

• ClinicalTrials.gov Identifier: NCT01966497
• Recruitment Status: Unknown
• First Posted: October 21, 2013
• Last Update Posted: November 20, 2017
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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

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 *: Gardin C, Pautas C, Fournier E, Itzykson R, Lemasle E, Bourhis JH, Adès 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, Terré 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.

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

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
• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: November 2017