Trial Information

SEIFEM 2010: Epidemiological Survey on Possible Pre-Hospital Risk Factors for Developing Invasive Fungal Infections in Patients Affected by Acute Myeloid Leukemia

SEIFEM 2010:

EPIDEMIOLOGICAL SURVEY ON POSSIBLE PRE-HOSPITAL RISK FACTORS FOR DEVELOPING INVASIVE FUNGAL
INFECTIONS IN PATIENTS AFFECTED BY ACUTE MYELOID LEUKEMIA

Background:

In two different multicenter surveys conducted in Italy from 1988-1997 and 1999-2003,
(Invasive Fungal Infections) IFIs were found to be a frequent cause of morbidity and
mortality in patients treated with conventional chemotherapies, particularly in those
suffering from acute myeloid leukemia (AML).

In general, the major factors that have been recognized as influencing the likelihood of
invasive fungal infection are the patient's immune status, the degree of any organ damage
(e.g., mucositis), and overall microbial exposure (i.e., colonization, environment, and
prior infection). Since the 1990s, different risk-stratification strategies have been
evaluated in order to identify those patients who may benefit from intensive prophylactic
and diagnostic measures. However, despite having similar risk profiles, only a subset of AML
patients will develop an IFI. One of the most exciting recent advances in the understanding
of the epidemiology of IFIs is the recognition of the complexity of the host and the
identification of new host-related risk factors.

Aim of this study is to identify and analyze risk factors for developing an invasive fungal
infection in patients with newly diagnosed Acute Myeloid Leukemia, with particular interest
on pre-hospital risk factors.

Aims and objective:

- To identify high risk subjects that can take advantage of an antifungal prophylaxis or
an early antifungal treatment (preemptive treatment).

- To identify possible fungal infections sources for the period preceding the diagnosis
of leukemia, in particular those related to normal activities of daily life (e.g.
occupation, location and type of residence, consume of tobacco, alcohol or illicit
drugs and others).

- To analyze hospital-related sources of fungal infection, from well known predisposing
factors (i.e. duration and severity of neutropenia) to other like central venous
catheter, urinary catheter, comorbidities, etc.

- To analyze the impact of both the prophylactic regimen adopted and the antifungal
treatment.

Design:

- Prospective, multicenter, observational and clinical-epidemiological study.

- The study is expected to enroll at least 500 patients with newly diagnosed acute
myeloid leukemia, those eligible for treatment and those not eligible, within 2 years
or until the achievement of a statistically evaluable number of cases.

- SEIFEM 2010 is a noninterventional registry and therefore there will not be any any
change physicians' diagnostic and therapeutic choices, that remain related to local
guidelines.

- Every patient who accept to take part to the study, will be asked to read and sign an
informed consent.

- An apposite form, with a detailed epidemiological section, should be compiled by
clinicians for each enrolled patient.

- A complete information page on the study is supplied to each patient enrolled.

Data collection:

In the questionnaire, possible risk factors for invasive fungal infections, prior to the
onset of acute leukemia, are evaluated. The module consists of several sections:

- Personal information (age, sex, observation time of the case, AML subtype, performance
status at admission), patient data will be anonymous.

- Comorbidities (diabetes, chronic renal failure, COPD, chronic liver disease, previous
TBC)

- A section compiled by the patient about possible risk factors related to the daily
living habits (location and type of residence, profession, hobbies, pets, personal
hygiene, ambiental exposures, consume of tobacco, alcohol or illicit drugs and others)

- A second part of the form will be compiled at the time of evaluation after induction
chemotherapy (between 30 and 40 days after chemotherapy) or, for those not suitable for
conventional treatment, 30-40 days after diagnosis.

At the time of a diagnosis of fungal infection data on the type of infection, treatment and
course of infection will be evaluated.

Eligibility:

Adult and pediatric patients with newly diagnosed acute myeloid leukemia, both eligible and
not eligible for intensive chemotherapy. Since this is a noninterventional study,
therapeutic strategies remains related to local guidelines. Will be treated as cases all
patients with acute leukemia in first induction developing an Invasive Fungal Infection
according to international EORTC criteria for possible/probable/proven infections. Patients
who do not develop the infection will be used as a control group.

Participating centers:

Forty-three Italian divisions of Hematology will take part to the study, distributed among
universities and highly specialized hospitals located throughout the country.