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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528941
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: Lamivudine Other: No prophylaxis

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.

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Study Type : Observational
Estimated Enrollment : 158 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


Group/Cohort Intervention/treatment
Lamivudine
Patients who received lamivudine
Drug: Lamivudine
Patients who received lamivudine to prevent hepatitis B

No prophylaxis
Patients who did not receive any prophylaxis
Other: No prophylaxis
Patients who did not receive any prophylaxis to prevent hepatitis B




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CLL with previous HBV exposure treated with at least one dose of Ibrutinib.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528941


Contacts
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Contact: Paola Fazi 0670390528 p.fazi@gimema.it
Contact: Enrico Crea 0670390514 e.crea@gimema.it

Locations
Show Show 17 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Luca Laurenti Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03528941    
Other Study ID Numbers: LLC1618
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Lymphocytic Leukemia
Hepatitis B
Ibrutinib
Additional relevant MeSH terms:
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Hepatitis B
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hepatitis
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Leukemia, B-Cell
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents