Biological and Clinical Efficacy of Shingrix in Patients With CLL

NCT06364033 | Not Yet Recruiting

• 1 other identifier: CLL2624
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; CLL-like MBL; Varicella-zoster Virus Reactivation

Outcome Measures

Primary Outcomes (1)

• Serologic response evaluation

  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)

  at 1 month

Interventions

serologic response evaluation BIOLOGICAL

Blood samples collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (1)

UOC Ematologia ASST dei Sette Laghi

Varese, Italy

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Coscia

  UOC Ematologia ASST Sette Laghi Varese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (1)