Biological and Clinical Efficacy of Shingrix in Patients With CLL

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • serologic response evaluation

Treatment groups

No treatment groups listed