Chronic Lymphocytic Leukemia
Conditions
Keywords
Chronic Lymphocytic Leukemia, Hepatitis B, Ibrutinib
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.
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.
Interventions
DRUGLamivudine
Patients who received lamivudine to prevent hepatitis B
OTHERNo prophylaxis
Patients who did not receive any prophylaxis to prevent hepatitis B
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients managed by prophylaxis | After 12 months from the first administration of Ibrutinib | number of patients managed by lamivudine prophylaxis |
| 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 |
| 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. |
| 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 |
Countries
Italy
Outcome results
None listed