Vaccine Responses in Patients With B Cell Malignancies

Обзор

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.

Подробное описание

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:

Determine vaccine titers following vaccination in patients with B-cell malignancies who are either receiving targeted therapies or not receiving active treatment

Endpoints:

The primary efficacy endpoint will be the serologic titer against each administered vaccine following completion of the vaccine series in each study arm

Secondary Endpoints: N/A

Вмешательства

• Препарат AREXVY, ABRYSVO
  Respiratory Syncytial Virus Vaccine
• Препарат PREVNAR 20
  Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
• Биопрепарат PNEUMOVAX 23
  Pneumococcal Polysaccharide Vaccine (PPSV23)
• Биопрепарат Heplisav -B
  Recombinant, adjuvanted Hepatitis (HepB-CpG)
• Биопрепарат PREVNAR 13
  Pneumococcal Conjugate Vaccine (PCV13)
• Биопрепарат Shingrix
  Recombinant, adjuvanted Zoster Vaccine (RZV)

Первичные конечные точки

• Serologic response against each administered vaccine following completion of the vaccine series in each study arm [Срок оценки: 4 weeks after completing vaccine series]

Критерии участия

• 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

Or

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT05170399 · 10000444 · 000444-H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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