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Trial record 75 of 339 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03528941
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
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 Lymphoid Leukemia Drug: Lamivudine Other: No prophylaxis

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
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


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 treatment with Ibrutinib ]

Secondary Outcome Measures :
  1. Number of patients having received prophylaxis after ibrutinib [ Time Frame: After 12 months from the first treatment with Ibrutinib ]
  2. Number of patients not having received any prophylaxis after ibrutinib [ Time Frame: After 12 months from the first treatment with Ibrutinib ]
  3. Number of adverse events in patients having received prophylaxis [ Time Frame: After 12 months from the first treatment with Ibrutinib ]
  4. Number of adverse events in patients having received no prophylaxis [ Time Frame: After 12 months from the first treatment with Ibrutinib ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CLL having been 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 March 31, 2017.
  • 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
Contact: Paola Fazi +393203671224 p.fazi@gimema.it
Contact: Enrico Crea +393203671224 e.crea@gimema.it

Locations
Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma Not yet recruiting
Roma, Italy
Contact: Gianluigi Reda         
Principal Investigator: Gianluigi Reda         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Luca Laurenti Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma
Study Director: Gianluigi Reda Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03528941     History of Changes
Other Study ID Numbers: LLC1618
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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 Lymphoid Leukemia
Hepatitis B
Ibrutinib

Additional relevant MeSH terms:
Hepatitis
Leukemia, Lymphocytic, Chronic, B-Cell
Hepatitis B
Leukemia, B-Cell
Hepatitis, Viral, Human
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
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