Ricerc@Sapienza

Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in Western countries, accounting for approximately 30% of all leukemias. Infections are the major cause of morbidity and mortality of CLL patients and represent the clinical effects of a multi-factorial immunodeficiency related to the underlying disease, treatment and the older age of patients.
Severe infections, were reported in 12.8-26% of treatment naive (TN) and relapsed/ refractory (R/R) patients treated with the bendamustine and rituximab (BR) chemoimmunotherapy in controlled trials (CT). Kinase inhibitors (KIs) of the B-cell receptor (BCR) patway have allowed remarkable improvements in the outcome of CLL patients. These agents will be soon considered as the preferable option for the treatment of a large proportion of patients, including elderly and unfit patients.
However, infections still represent an important cause of morbidity also in patients treated with the KIs ibrutinib or idelalisib. In a CT 27% of R/R patients developed a severe infection while on ibrutinib treatment. Infections, are common also in patients treated with idelalisib. In CTs including R/R patients treated with idelalisib combined with rituximab severe infections were described in 29% of the cases.
Little is known about the infection rate and factors associated with an increased risk of infections in R/R patients with CLL treated with BR or KIs inhibitors in the real world.
The purpose of this multicenter, retrospective study that will include a large series of patients with CLL, is to define the proportion of unselected patients treated in the real world who develop a severe infection after treatment with BR or KIs. In addition, we will investigate factors associated with an increased risk of infections. The results of this study could be of help in the decision-making process to address the optimal treatment choice and the adequate infection prophylaxis in CLL patients.