Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lamivudine | Drug | — | UNRESOLVED |
| No prophylaxis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lamivudine
- description
- Patients who received lamivudine
- interventionNames
- Drug: Lamivudine
- label
- No prophylaxis
- description
- Patients who did not receive any prophylaxis
- interventionNames
- Other: No prophylaxis
Primary outcomes (1)
- measure
- Number of patients with hepatitis B reactivation
- timeFrame
- After 12 months from the first administration of Ibrutinib
- description
- The primary objective of the Study is to evaluate the incidence of HBV reactivation cases in patients affected by CLL treated with Ibrutinib.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available