💬In plain words
What the trial is, and whether it could suit you
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 g
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* 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:
1. 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
2. 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
EXCLUSION CRITERIA:
1. Female patients who are currently pregnant
2. History of severe allergic reaction to vaccines
3. Concomitant inherited immunodeficiency
4. 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.
5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
7. Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
9. History of allogeneic stem cell transplantation
💊
What it tests
- AREXVY, ABRYSVO
- PREVNAR 20
- PNEUMOVAX 23
- Heplisav -B
- PREVNAR 13
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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