Ireland
--:--IST
Starting soon Not applicable

Biological and Clinical Efficacy of Shingrix in Patients With CLL

NCT06364033 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-08
Last updated
2024-05-09

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaCLL-like MBLVaricella-zoster Virus Reactivation

Investigational drug(s) / intervention(s)

serologic response evaluation

serologic response evaluation: Blood samples collection

Study summary

This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Serologic response evaluation — at 1 month
    Rate of positive serologic response to Shingrix in different subsets of patients as determined by antibody response to varicella-zoster virus (≥4-fold increase in anti-gE titer from baseline)

Trial sites (1)

FacilityCityRegionStatus
UOC Ematologia ASST dei Sette Laghi Varese Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06364033 on ClinicalTrials.gov ↗ ← All trials in Italy