Serologic Response to a New Recombinant, Adjuvanted Herpes Zoster Vaccine in Patients With Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia Treated With First-Line BTK Inhibitors - A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
研究概览
简要总结
The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
详细描述
Chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM) are known risk factors for zoster reactivation, commonly called shingles. Although a recently FDA-approved recombinant, adjuvanted herpes zoster vaccine (Shingrix) is currently being offered to these populations, no study has specifically evaluated them.
The purpose of the study is to complete a single-arm trial evaluating if patients with CLL or WM, while on treatment with first-line BTK inhibitors, can achieve immunologic response to Shingrix. If effective, this will result in a new, well-tolerated shingles prevention strategy for these patients.
The primary objective is to assess the capability to mount a humoral immune response to Shingrix in patients with CLL or WM under first-line BTK inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are at least 50 years of age;
- •Have been diagnosed with chronic lymphocytic leukemia (CLL) OR Waldenström's macroglobulinemia (WM)
- •Have been on first-line BTK inhibitor (ie ibrutinib or acalabrutinib) for at least 3 months,
- •Prior treatment with single agent rituximab is permitted if last dose was administered over one year ago;
- •Have at least a one-year life expectancy;
- •Have a history of varicella (chicken-pox) OR lived in the US or any endemic country for > 30 years.
- •Prior radiation therapy is allowed
排除标准
- •They have a known hypersensitivity to a vaccine component;
- •Had herpes zoster reactivation within the past year;
- •Had received or were scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days post-second dose;
- •Had received or were scheduled to receive an inactivated vaccine in the period ranging from 7 days prior to Dose 1 through 7 days post- second dose;
- •Are unable to give informed consent;
- •Have absolute lymphocyte counts greater than 20,000 X 109/L;
- •Are receiving treatment for CLL or WM with an additional agent other than a BTK inhibitor;
- •Had rituximab treatment within a year prior to study start;
- •Had prior chemotherapy.
研究组 & 干预措施
Shingrix shingles vaccine treatment
On day one, patients will receive the first of two doses of the Shingrix vaccine administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
干预措施: Shingrix vaccine (Drug)
结局指标
主要结局
Number of Participants With Humoral Response to Vaccination 4 Weeks After the Second Vaccine Administration
时间窗: 4 weeks following the second vaccination, at approximately 3 months
Vaccine response, as determined by blood antibody levels to the varicella virus glycoprotein E subunit (anti-gE); Baseline is defined as pre-vaccination anti-gE titer in seropositive subjects, and the lower limit of detection in seronegative subjects
次要结局
- Number of Participants With Cellular Response to Vaccination 4 Weeks After the Second Vaccine Administration(4 weeks following the second vaccination, at approximately 3 months)
研究者
Jonathan Friedberg
Director of the Wilmot Cancer Institute
University of Rochester