The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
NCT ID: NCT03528941
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
109 participants
OBSERVATIONAL
2018-11-28
2021-06-30
Brief Summary
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Detailed Description
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The aim of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Lamivudine
Patients who received lamivudine
Lamivudine
Patients who received lamivudine to prevent hepatitis B
No prophylaxis
Patients who did not receive any prophylaxis
No prophylaxis
Patients who did not receive any prophylaxis to prevent hepatitis B
Interventions
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Lamivudine
Patients who received lamivudine to prevent hepatitis B
No prophylaxis
Patients who did not receive any prophylaxis to prevent hepatitis B
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Luca Laurenti
Role: PRINCIPAL_INVESTIGATOR
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
Locations
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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
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
Countries
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Related Links
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GIMEMA Foundation website
Other Identifiers
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LLC1618
Identifier Type: -
Identifier Source: org_study_id
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