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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT01966497

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloblastic Leukemia Aged Higher Than 60 Years Old

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 1, 2012

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

cumulative incidence of failures [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

response rate [9 months]
relapse rate [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 [within 2 years after inclusion]
adverse events [within 2 years after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Avicenne	Bobigny	Ile De France	France	93

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01966497

Other Study ID Numbers:

NI11020

First Posted:

Oct 21, 2013

Last Update Posted:

Nov 20, 2017

Last Verified:

Nov 1, 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris

AML

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Nov 20, 2017