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NCT Number: NCT03528941

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Liver Diseases Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione, Cona, Ferrara, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lamivudine

Drug

Patients who received lamivudine to prevent hepatitis B

No prophylaxis

Other

Patients who did not receive any prophylaxis to prevent hepatitis B

Primary outcomes

  1. Number of patients with hepatitis B reactivation

    Time frame: 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 outcomes

  1. Rate of patients managed by prophylaxis

    Time frame: After 12 months from the first administration of Ibrutinib

    number of patients managed by lamivudine prophylaxis

  2. Rate of patients undergoing strict follow-up only

    Time frame: After 12 months from the first administration of Ibrutinib

    number of patients who did not receive any prophylaxis

  3. Rate of HBV reactivation according to patient status and prophylaxis

    Time frame: 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.

  4. Rate of adverse events during ibrutinib treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Acronym: LLC1618

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 18, 2018
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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