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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamivudine | Patients who received lamivudine |
| |
| No prophylaxis | Patients who did not receive any prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug | Patients who received lamivudine to prevent hepatitis B |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 12 months from the first administration of Ibrutinib |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients managed by prophylaxis | number of patients managed by lamivudine prophylaxis | After 12 months from the first administration of Ibrutinib |
| Rate of patients undergoing strict follow-up only |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.
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| Name | Affiliation | Role |
|---|---|---|
| Luca Laurenti | Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione | Cona | Ferrara | Italy | |||
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| Label | URL |
|---|---|
| GIMEMA Foundation website | View source |
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| No prophylaxis |
| Other |
Patients who did not receive any prophylaxis to prevent hepatitis B |
|
number of patients who did not receive any prophylaxis
| 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. | 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 | After 12 months from the first administration of Ibrutinib |
| 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 |
| IRCCS Ospedale San Raffaele - Unità neoplasie linfocitarie B | Milan | Italy |
| Aou Di Modena - Sc Ematologia | Modena | Italy |
| AOU Maggiore della Carità di Novara - SCDU Ematologia | Novara | 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 |
| Policlinico Universitario Campus Bio Medico - UOC Ematologia e Trapianto di cellule staminali | 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 |
| AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia | Torino | Italy |
| Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia | Verona | Italy |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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