Vaccine Responses in Patients With B Cell Malignancies
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Serologic response against each administered vaccine following completion of the vaccine series in each study arm
研究概览
简要总结
Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses, such as vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses.
Participants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series.
Participants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination.
Participants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.
详细描述
Study Description:
This study aims to determine vaccine titers in B-cell malignancies; specifically, in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL) [follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphomas (MZLs) and indolent NHL not otherwise specified (NOS)], or in Waldenstrom Macroglobulinemia (WM).
Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified.
Objectives:
Primary Objective:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM
- •Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:
- •Patients with CLL AND one of the following:
- •i. Arm 1: Must be treatment naive (no prior cancer directed therapy)
- •ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment
- •iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine
- •iv. Arm 4: Must be receiving treatment with a BTKi for >= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.
- •v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor
- •Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:
- •i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)
- •ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)
- •If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
- •Age >= 18 years
- •Able to comprehend the investigational nature of the protocol and provide informed consent
排除标准
- •Female patients who are currently pregnant
- •History of severe allergic reaction to vaccines
- •Concomitant inherited immunodeficiency
- •Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk.
- •Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
- •Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
- •Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
- •Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
- •History of allogeneic stem cell transplantation
研究组 & 干预措施
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Chronic Lymphocytic Leukemia Treatment with BTKi
Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Chronic Lymphocytic Leukemia Treatment with BTKi
Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Chronic Lymphocytic Leukemia Treatment with BTKi
Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Chronic Lymphocytic Leukemia Treatment with BTKi
Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia Treatment with BTKi
Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia Treatment Naive
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Heplisav -B (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: AREXVY, ABRYSVO (Drug)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: Shingrix (Biological)
Chronic Lymphocytic Leukemia Treatment Break for BTKi
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 13 (Biological)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PREVNAR 20 (Drug)
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
干预措施: PNEUMOVAX 23 (Biological)
结局指标
主要结局
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
时间窗: 4 weeks after completing vaccine series
vaccine titer
次要结局
未报告次要终点