Clinical trial NCT03528941: The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
Official title: Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Hepatitis B
Ibrutinib
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* CLL/small lymphocytic lymphoma (SLL) patients.
* Patients treated with single-agent Ibrutinib (at least one dose) outside interventional clinical trials before January 31, 2019.
* Serology positive with previous HBV/OBI (HBsAg negatives, anti-HBc positives with or without anti-HBs) infection.
* Signed written informed consent, if applicable, indicating study scope and procedure understanding.

Exclusion Criteria:

* Patients who did not undergo hepatitis B screening before starting the Ibrutinib therapy.
* Patients affected by CLL treated with Ibrutinib vaccinated against hepatitis B or with serology not compatible with a previous infection.
* Patients affected by HCV, HIV or with other causes of liver disease.
* Patients enrolled in clinical trials including Ibrutinib administered in combination with other drugs.
* Patients positive for active hepatitis B.

Primary outcomes:
measure: Number of patients with hepatitis B reactivation
timeFrame: After 12 months from the first administration of Ibrutinib
Secondary outcomes:
measure: Rate of patients managed by prophylaxis
timeFrame: After 12 months from the first administration of Ibrutinib
measure: Rate of patients undergoing strict follow-up only
timeFrame: After 12 months from the first administration of Ibrutinib
measure: Rate of HBV reactivation according to patient status and prophylaxis
timeFrame: After 12 months from the first administration of Ibrutinib
measure: Rate of adverse events during ibrutinib treatment
timeFrame: After 12 months from the first administration of Ibrutinib
Other outcomes:
Locations:
city: Cona
country: Italy
facility: AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
state: Ferrara
city: Bari
country: Italy
facility: AOU Consorziale Policlinico - UO Ematologia con Trapianto
city: Brescia
country: Italy
facility: ASST degli Ospedali Civili di Brescia - UO Ematologia
city: Cagliari
country: Italy
facility: AO Brotzu, Presidio Ospedaliero A.Businco - SC Ematologia e CTMO
city: Catania
country: Italy
facility: CTC U.O. di Ematologia con Trapianto di midollo osseo - Catania
city: Catanzaro
country: Italy
facility: AO di Catanzaro "Pugliese - Ciaccio", Presidio Ospedaliero "Ciaccio - De Lellis" - Ematologia
city: Cosenza
country: Italy
facility: Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia
city: Genova
country: Italy
facility: IRCCS AOU San Martino - UO Ematologia e Trapianti
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico - Ematologia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele - Unità neoplasie linfocitarie B
city: Modena
country: Italy
facility: Aou Di Modena - Sc Ematologia
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara - SCDU Ematologia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo - OU Ematologia
city: Pescara
country: Italy
facility: Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
city: Pisa
country: Italy
facility: AOU Pisana - UO Ematologia Universitaria
city: Roma
country: Italy
facility: AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Area Ematologica
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio Medico - UOC Ematologia e Trapianto di cellule staminali
city: Roma
country: Italy
facility: Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
city: Siena
country: Italy
facility: Aou Senese - Uoc Ematologia E Trapianti
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
city: Verona
country: Italy
facility: Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Study officials:
affiliation: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
name: Luca Laurenti
role: PRINCIPAL_INVESTIGATOR
References: