This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.
This observational retrospective study will enroll at least 158 patients affected by CLL with previous HBV exposure (HBsAg negative, anti HBc positive with or without anti-HBs) treated with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided in two cohorts one encompassing patients receiving lamivudine and the second one including patients who will not be given any prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib. The aim of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Study Type
OBSERVATIONAL
Enrollment
109
Patients who received lamivudine to prevent hepatitis B
Patients who did not receive any prophylaxis to prevent hepatitis B
AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
Cona, Ferrara, Italy
AOU Consorziale Policlinico - UO Ematologia con Trapianto
Bari, Italy
ASST degli Ospedali Civili di Brescia - UO Ematologia
Brescia, Italy
AO Brotzu, Presidio Ospedaliero A.Businco - SC Ematologia e CTMO
Cagliari, Italy
CTC U.O. di Ematologia con Trapianto di midollo osseo - Catania
Catania, Italy
AO di Catanzaro "Pugliese - Ciaccio", Presidio Ospedaliero "Ciaccio - De Lellis" - Ematologia
Catanzaro, Italy
Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
Cosenza, Italy
IRCCS AOU San Martino - UO Ematologia e Trapianti
Genova, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico - Ematologia
Milan, Italy
...and 13 more locations
Number of patients with hepatitis B reactivation
The primary objective of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Time frame: After 12 months from the first administration of Ibrutinib
Rate of patients managed by prophylaxis
number of patients managed by lamivudine prophylaxis
Time frame: After 12 months from the first administration of Ibrutinib
Rate of patients undergoing strict follow-up only
number of patients who did not receive any prophylaxis
Time frame: After 12 months from the first administration of Ibrutinib
Rate of HBV reactivation according to patient status and prophylaxis
Incidence of HBV reactivation related to patient clinical, biological and therapeutic characteristics, especially in connection with the different incidence of reactivation in patients who received lamivudine prophylaxis versus patients observed with a strict follow-up.
Time frame: After 12 months from the first administration of Ibrutinib
Rate of adverse events during ibrutinib treatment
Safety profile in patients who received lamivudine prophylaxis versus patients observed with a strict follow-up
Time frame: After 12 months from the first administration of Ibrutinib
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