The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
- Registration Number
- NCT03528941
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No prophylaxis No prophylaxis Patients who did not receive any prophylaxis Lamivudine Lamivudine Patients who received lamivudine
- Primary Outcome Measures
Name Time Method Number of patients with hepatitis B reactivation After 12 months from the first administration of Ibrutinib The primary objective of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
- Secondary Outcome Measures
Name Time Method Rate of adverse events during ibrutinib treatment After 12 months from the first administration of Ibrutinib Safety profile in patients who received lamivudine prophylaxis versus patients observed with a strict follow-up
Rate of patients managed by prophylaxis After 12 months from the first administration of Ibrutinib number of patients managed by lamivudine prophylaxis
Rate of patients undergoing strict follow-up only After 12 months from the first administration of Ibrutinib number of patients who did not receive any prophylaxis
Rate of HBV reactivation according to patient status and prophylaxis After 12 months from the first administration of Ibrutinib 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.
Trial Locations
- Locations (23)
AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
🇮🇹Cona, Ferrara, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
🇮🇹Novara, Italy
AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia
🇮🇹Torino, 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
🇮🇹Milano, Italy
Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico - Ematologia
🇮🇹Milano, Italy
IRCCS Ospedale San Raffaele - Unità neoplasie linfocitarie B
🇮🇹Milano, Italy
Aou Di Modena - Sc Ematologia
🇮🇹Modena, Italy
Fondazione IRCCS Policlinico San Matteo - OU Ematologia
🇮🇹Pavia, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
🇮🇹Pescara, Italy
AOU Pisana - UO Ematologia Universitaria
🇮🇹Pisa, Italy
AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali
🇮🇹Roma, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Area Ematologica
🇮🇹Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
🇮🇹Roma, Italy
Aou Senese - Uoc Ematologia E Trapianti
🇮🇹Siena, Italy
Policlinico Universitario Campus Bio Medico - UOC Ematologia e Trapianto di cellule staminali
🇮🇹Roma, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
🇮🇹Verona, Italy