MULTICENTRIC OBSERVATIONAL RETROSPECTIVE STUDY ON BACTERIAL / FUNGAL / VIRAL INFECTIONS IN PATIENTS WITH SECONDARY ACUTE MYELOID LEUKEMIA TREATED WITH DAURORUBICIN-CITARABINE LIPOSOMIAL (VYXEOS) IN THE “REAL-LIFE”

PHASE OF THE STUDY:

Retrospective observational

Objectives of the study:

Primary

– To evaluate the absolute infectious risk in the real-life setting of patients with AML treated with Vyxeos

Secondary

– To evaluate the type, incidence and outcome of bacterial / fungal / viral infections in this kind of patients

– To assess the infection-related mortality rate with stratification for each AML subtype (therapy-related AML, secondary to myelodysplastic syndrome, AML with myelodysplasia-related changes)

–  To evaluate the length of inpatient stay.

Study design:

The proposed clinical-epidemiological study is retrospective, observational, multicentric including

all Hematological centers that used Vyxeos for the treatment of patients with AML over the past 2 years.

Data will be retrospectively collected, for each individual patient, who has expressed informed consent, and for all cases observed between 1 July 2018 and  June 2020.

Database, compiled with the omission of any reference allowing patient identification, will require information relating to the infectious event and its treatment, including the outcome at 4, 8 and 12 weeks.

Population:

• All patients with therapy-related, secondary AML or acute myeloid leukemia with myelodysplasia related changes treated with Vyxeos as first induction.