Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
研究概览
简要总结
Background:
People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL.
Objective:
To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL).
Eligibility:
Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments.
Design:
Participants will be screened with a chart review or through another protocol.
Visit 1
At visit 1, participants may have a pregnancy test, blood test, or physical exam.
Pregnant participants cannot be in the study.
Eligible participants will get the shingles vaccine as an injection.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 2
Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine.
Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines.
Visit 3
Visit 3 will be 3 months after visit 2. Participants will have blood taken.
Participants may be able to get an additional vaccine the same day as the shingles vaccine.
详细描述
This study aims to determine the efficacy of the SHINGRIX varicella zoster virus (VZV) vaccine in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients that are treatment naive or receiving Bruton s-tyrosine kinase inhibitor (BTK-I). (Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified).
Key Eligibility Criteria:
- Diagnosis of CLL or SLL
- Cohort 1: Treatment naive CLL or SLL patients
- Cohort 2: Subjects must be receiving ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose
- Age greater than or equal to 18 years
- ECOG performance status of 0-1
Design:
Patients with CLL will enroll on the study for the purpose of determining the SHINGRIX vaccine efficacy in patients who are treatment naive or receiving BTK-I therapy. A series of 2 doses of SHINGRIX will be given at 0- and 3- month schedule by intramuscular injection. Subjects will be followed for 6 months and receive assessment of serologic response 6 months after the first vaccine dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
时间窗: 6 months after the first vaccine administration
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
次要结局
- Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.(6 months after the first vaccine administration)
- Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.(6 months after the first vaccine administration)