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

NCT03528941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 109

Last updated 2022-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lamivudine

Patients who received lamivudine to prevent hepatitis B

OTHER

No prophylaxis

Patients who did not receive any prophylaxis to prevent hepatitis B

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Luca Laurenti · Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2021-03-26
Completion
2021-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528941 on ClinicalTrials.gov