Vaccine Responses in Patients With B Cell Malignancies

This is an interventional basic science trial for Lymphoma focused on measuring CLL, SLL, Booster, Lymphoma, Vaccines Read More

• 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