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Not yet recruiting NCT06364033

Biological and Clinical Efficacy of Shingrix in Patients With CLL

No phase Interventional Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma CLL-like MBL Varicella-zoster Virus Reactivation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: serologic response evaluation.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL-like MBL, Varicella-zoster Virus Reactivation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia

Overview

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.

Detailed description

This is a multi-centre, prospective study, performed on biological samples only. 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. All protocol procedures (including clinical assessment and blood draws) will be performed during regular follow-up visits according to clinical practice. No additional invasive/dangerous/painful procedures will be required by the study.

Interventions

  • Biological serologic response evaluation
    Blood samples collection

Primary outcome measures

  • Serologic response evaluation [Time frame: at 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Italy · 1 center
  • UOC Ematologia ASST dei Sette Laghi — Varese

Identifiers

NCT: NCT06364033 · CLL2624

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗