Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT06364033
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06364033
Study Brief:
Protocol Section:
NCT06364033