The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
LLC1618
Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
1 other identifier
observational
109
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
November 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedMay 12, 2022
May 1, 2022
2.3 years
May 7, 2018
May 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Rate of patients managed by prophylaxis
After 12 months from the first administration of Ibrutinib
Rate of patients undergoing strict follow-up only
After 12 months from the first administration of Ibrutinib
Rate of HBV reactivation according to patient status and prophylaxis
After 12 months from the first administration of Ibrutinib
Rate of adverse events during ibrutinib treatment
After 12 months from the first administration of Ibrutinib
Study Arms (2)
Lamivudine
Patients who received lamivudine
No prophylaxis
Patients who did not receive any prophylaxis
Interventions
Patients who did not receive any prophylaxis to prevent hepatitis B
Eligibility Criteria
Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Laurenti
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 18, 2018
Study Start
November 28, 2018
Primary Completion
March 26, 2021
Study Completion
June 30, 2021
Last Updated
May 12, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share