Vaccine Responses in Patients With B Cell Malignancies

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 25, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well vaccines work for patients with certain types of blood cancers known as B cell malignancies, such as chronic lymphocytic leukemia (CLL) and lymphoma. Many people with these conditions may not respond as effectively to vaccines, especially if they are on specific treatments called Bruton tyrosine kinase inhibitors (BTKis). By studying how these patients respond to vaccines like those for COVID-19 and hepatitis B, researchers hope to find better ways to protect them from infections.

To participate in the study, you need to be an adult aged 18 or older and have one of the eligible blood cancers. Participants will receive one or more vaccines and will have blood samples taken before and after vaccination to check how their immune system responds. Some people may also have the option to get booster shots. The study may last up to five years, with a few visits required during that time. It’s important to note that if you are receiving specific treatments for your cancer, you may need to pause them for a short period around the time of vaccination. This research aims to help improve vaccine strategies for those with blood cancers, making it a valuable opportunity for patients.

Gender

ALL

Eligibility criteria

• * 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