Biological and Clinical Efficacy of Shingrix in Patients With CLL

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of the Shingrix vaccine in patients with Chronic Lymphocytic Leukemia (CLL) and related conditions. The goal is to see how well the vaccine helps boost the immune response against the varicella-zoster virus, which can cause shingles. If you are an adult aged 18 or older with a diagnosis of CLL or small lymphocytic lymphoma, and you meet certain health criteria, you might be eligible to participate. This includes being eligible to receive the vaccine through the Italian National Health System and not having any recent infections or treatments that could interfere with the vaccine.

If you join the study, you will receive two doses of the Shingrix vaccine, spaced 4 to 8 weeks apart. Researchers will take blood samples before your first dose and at several points afterward to check how your body is responding to the vaccine. It’s important to know that this trial is not yet recruiting participants, so you’ll need to wait for further announcements if you’re interested in taking part. Additionally, you will need to provide informed consent and follow the study guidelines throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines. Patients must belong to one of the following subgroups:
• • Group A: Patients with MBL or previously untreated early-phase CLL/SLL (Binet stage A or RAI stage 0), with no clear signs of disease progression;
• • Group B: Patients with active or symptomatic disease according to IWCLL guidelines or with advanced Binet or Rai stages receiving both the first and second vaccine doses before treatment initiation;
• • Group C: Patients with CLL/SLL receiving targeted drugs (i.e. ibrutinib/acalabrutinib-based treatment or venetoclax-based treatment) for at least 6 months prior to the administration of the first vaccine dose.
• • Age 18 years or older
• • Eligible to receive Shingrix according to clinical indication and free of charge through the Italian National Health System
• • Life expectancy \>6 months
• • No active, symptomatic herpes zoster infection or varicella-zoster virus reactivation within 12 months prior to vaccination
• • No prior exposure to Shingrix
• • Able and willing to provide written informed consent and to comply with the study protocol procedures
• Exclusion Criteria:
• • Female patients who are currently in pregnancy or are willing to be pregnant
• • Any uncontrolled active systemic infection
• • Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination
• • Concomitant use of radiotherapy or chemotherapy
• • Hereditary or acquired immunodeficiency syndrome unrelated to CLL
• • Chronic use of immunosuppressive medications given for indications that are not CLL-related