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Prospective Survey on Severe Infections During a Multicenter Study of Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia.

18 Years
60 Years
Not Enrolling
AML, Adult

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Trial Information

Prospective Survey on Severe Infections During a Multicenter Study of Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia.

Treatment of AML patients during chemotherapy and SCT is frequently complicated by SI which
may represent an obstacle to the antileukemic chemotherapy and transplant program.
Antimicrobial prophylaxis, diagnostic approaches and antimicrobial therapy should be adapted
to the infectious risk of the leukemic population. A crucial problem in the definition of
these strategies is represented by the continuous change in the epidemiological patterns of
infections as a result of the modification of risk factors in the leukemic population and of
the global epidemiology of hospital and community acquired infections. In particular, the
emergence of antibiotic resistant pathogens, particularly among gram negative bacteria,
represents a serious problem which dramatically impacts on the antibacterial prophylaxis
and treatments choices. A continuous epidemiology survey is required in order to better
define proper prevention, diagnostic and treatment approaches. A common problem in the
infections control in immunocompromised populations is represented by a late epidemiological
consciousness. In particular, when new antileukemic strategies are implemented any change in
the infectious epidemiology is frequently evidenced later retrospectively, but retrospective
studies suffer of several drawbacks in the timely and proper collection of data.

The aim of the AML1310 GIMEMA protocol is to prospectively evaluate in a large population of
newly diagnosed young AML patients the effect of a risk-adapted, MDR directed antileukemic
strategy which includes chemotherapy and SCT. The objective of the trial is to evaluate the
treatment strategy in terms of OS at 24 months and secondary objectives include the response
rates and outcome according to clinical and biological characteristics at baseline and along
the antileukemic treatment. A further secondary objective of the AML1310 study is the
evaluation of the quality of life.

A prospective, longitudinal survey of infectious complications occurring in patients
enrolled in the AML1310 study along the entire antileukemic program, as an ancillary
observational study, may be a useful tool to evaluate in real-time the epidemiological
patterns of infections, their impact on the OS, on the antileukemic treatment schedule, and
on the quality of life. First, it may allow to assess whether the various types of SI, in
addition to well known clinical and leukemia-related prognostic variables, are actually
independent prognostic factors for the long-term outcome of AML patients. Second, the
results of this survey may offer precious indications for the timely update of the
prophylaxis , diagnosis and treatment strategies of infections in AML patients undergoing a
modern antileukemic program. The advances in the treatment of AML resulting from the AML1310
study may be further enriched by the epidemiological consciousness derived by a parallel
survey of the infectious complications.

Inclusion Criteria:

- All patients enrolled in the GIMEMA AML1310 study;

- Signed written informed consent according to ICH/EU/GCP and national local laws.

Exclusion Criteria:

- Patients not eligible for the GIMEMA AML1310 study.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prognostic role on overall survival

Outcome Description:

At 24 months of each type of Severe Infection (SI).

Outcome Time Frame:

At four years from study entry.

Safety Issue:


Principal Investigator

Adriano VENDITTI, Pr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Policlinico Tor Vergata di Roma


Italy: Ethics Committee

Study ID:




Start Date:

June 2012

Completion Date:

June 2016

Related Keywords:

  • AML
  • Adult
  • AML
  • adult
  • AML1310 GIMEMA study
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid