The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib

Chronic Lymphocytic Leukemia Clinical Trial

— LLC1618  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528941
• Other study ID #: LLC1618
• Status: Completed
• Start date: November 28, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2022
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 30, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Hepatitis
• Hepatitis B
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Lamivudine
Patients who received lamivudine to prevent hepatitis B

Other:
• No prophylaxis
Patients who did not receive any prophylaxis to prevent hepatitis B

Locations

Country	Name	City	State
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	AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione	Cona	Ferrara
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of patients managed by prophylaxis	number of patients managed by lamivudine prophylaxis	After 12 months from the first administration of Ibrutinib
Secondary	Rate of patients undergoing strict follow-up only	number of patients who did not receive any prophylaxis	After 12 months from the first administration of Ibrutinib
Secondary	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
Secondary	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

External Links

•   GIMEMA Foundation website