Biological and Clinical Efficacy of Shingrix in Patients With CLL

Korábbi kezelés

• Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination
• Concomitant use of radiotherapy or chemotherapy
• Chronic use of immunosuppressive medications given for indications that are not CLL-related

Más betegség

• Any uncontrolled active systemic infection
• Hereditary or acquired immunodeficiency syndrome unrelated to CLL

Egyéb

• Female patients who are currently in pregnancy or are willing to be pregnant

• 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