The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia W… (NCT03528941) | Clinical Trial Compass
CompletedNot Applicable
The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib
Italy109 participantsStarted 2018-11-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with hepatitis B reactivation
Timeframe: After 12 months from the first administration of Ibrutinib
Trial details
NCT IDNCT03528941
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto