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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib

Conditions
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Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Lamivudine
* Other: No prophylaxis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lamivudine<br>Patients who received lamivudine | Drug: Lamivudine<br>* Patients who received lamivudine to prevent hepatitis B<br>|
| No prophylaxis<br>Patients who did not receive any prophylaxis | Other: No prophylaxis<br>* Patients who did not receive any prophylaxis to prevent hepatitis B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, Hepatitis B, Ibrutinib