NCT03528941

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Lamivudine	Patients who received lamivudine to prevent hepatitis B
OTHER	No prophylaxis	Patients who did not receive any prophylaxis to prevent hepatitis B

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-03-26
• Completion: 2021-06-30
• First posted: 2018-05-18
• Last updated: 2022-05-12

Locations

23 sites across 1 country: Italy