Observational Retrospective Multicenter Study Aimed at Evaluating the Incidence of Hepatitis B Reactivation in Patients Affected by Chronic Lymphocytic Leukemia Treated With Ibrutinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 23
- 主要终点
- Number of patients with hepatitis B reactivation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CLL/small lymphocytic lymphoma (SLL) patients.
- •Patients treated with single-agent Ibrutinib (at least one dose) outside interventional clinical trials before January 31,
- •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.
排除标准
- •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.
研究组 & 干预措施
Lamivudine
Patients who received lamivudine
干预措施: Lamivudine (Drug)
No prophylaxis
Patients who did not receive any prophylaxis
干预措施: No prophylaxis (Other)
结局指标
主要结局
Number of patients with hepatitis B reactivation
时间窗: 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.
次要结局
- Rate of adverse events during ibrutinib treatment(After 12 months from the first administration of Ibrutinib)
- Rate of patients managed by prophylaxis(After 12 months from the first administration of Ibrutinib)
- Rate of patients undergoing strict follow-up only(After 12 months from the first administration of Ibrutinib)
- Rate of HBV reactivation according to patient status and prophylaxis(After 12 months from the first administration of Ibrutinib)