LLC1618: The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
• Overall Status: Completed
• CT.gov ID: NCT03528941
• Collaborator: (none)
• Enrollment: 109
• Locations: 23
• Actual Duration (Months): 31
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Lamivudine; Other: No prophylaxis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 109 participants
• Observational Model: Other
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Nov 28, 2018
• Actual Primary Completion Date: Mar 26, 2021
• Actual Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Lamivudine Patients who received lamivudine	Drug: Lamivudine; Patients who received lamivudine to prevent hepatitis B
No prophylaxis Patients who did not receive any prophylaxis	Other: No prophylaxis; Patients who did not receive any prophylaxis to prevent hepatitis B

Outcome Measures

Primary Outcome Measures

1. 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

1. Rate of patients managed by prophylaxis [After 12 months from the first administration of Ibrutinib]

   number of patients managed by lamivudine prophylaxis

2. 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

3. 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.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione	Cona	Ferrara	Italy
2	AOU Consorziale Policlinico - UO Ematologia con Trapianto	Bari		Italy
3	ASST degli Ospedali Civili di Brescia - UO Ematologia	Brescia		Italy
4	AO Brotzu, Presidio Ospedaliero A.Businco - SC Ematologia e CTMO	Cagliari		Italy
5	CTC U.O. di Ematologia con Trapianto di midollo osseo - Catania	Catania		Italy
6	AO di Catanzaro "Pugliese - Ciaccio", Presidio Ospedaliero "Ciaccio - De Lellis" - Ematologia	Catanzaro		Italy
7	Ao Di Cosenza, Presidio Ospedaliero Annunziata - Uoc Ematologia	Cosenza		Italy
8	IRCCS AOU San Martino - UO Ematologia e Trapianti	Genova		Italy
9	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano		Italy
10	Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico - Ematologia	Milano		Italy
11	IRCCS Ospedale San Raffaele - Unità neoplasie linfocitarie B	Milano		Italy
12	Aou Di Modena - Sc Ematologia	Modena		Italy
13	AOU Maggiore della Carità di Novara - SCDU Ematologia	Novara		Italy
14	Fondazione IRCCS Policlinico San Matteo - OU Ematologia	Pavia		Italy
15	Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica	Pescara		Italy
16	AOU Pisana - UO Ematologia Universitaria	Pisa		Italy
17	AOU Policlinico Tor Vergata - UOC Trapianto cellule staminali	Roma		Italy
18	Fondazione Policlinico Universitario A. Gemelli IRCCS - Area Ematologica	Roma		Italy
19	Policlinico Universitario Campus Bio Medico - UOC Ematologia e Trapianto di cellule staminali	Roma		Italy
20	Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia	Roma		Italy
21	Aou Senese - Uoc Ematologia E Trapianti	Siena		Italy
22	AOU Città della Salute e della Scienza, Ospedale S.Giovanni Battista Molinette - SC Ematologia	Torino		Italy
23	Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia	Verona		Italy

Sponsors and Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

• Principal Investigator: Luca Laurenti, Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• GIMEMA Foundation website

Publications

None provided.

• Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
• ClinicalTrials.gov Identifier: NCT03528941
• Other Study ID Numbers: LLC1618
• First Posted: May 18, 2018
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto: Chronic Lymphocytic Leukemia; Hepatitis B; Ibrutinib
• Additional relevant MeSH terms: Hepatitis B; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hepatitis; Lamivudine

Study Results

No Results Posted as of May 12, 2022