The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib (LLC1618)

G

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Completed

Conditions

Chronic Lymphocytic Leukemia

Treatments

Other: No prophylaxis
Drug: Lamivudine

Study type

Observational

Funder types

Other

Identifiers

NCT03528941
LLC1618

Details and patient eligibility

About

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.

Full 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.

Enrollment

109 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

109 participants in 2 patient groups

Lamivudine
Description:
Patients who received lamivudine
Treatment:
Drug: Lamivudine
No prophylaxis
Description:
Patients who did not receive any prophylaxis
Treatment:
Other: No prophylaxis

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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