NCT06364033Not yet recruiting
Biological and Clinical Efficacy of Shingrix in Patients With CLL
Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- Aug 2024
- Primary completion date
- Nov 2025
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT06364033
What you commit to
- Study type: Interventional
- Planned participants: 312
- From Aug 2024 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any uncontrolled active systemic infection
- Hereditary or acquired immunodeficiency syndrome unrelated to CLL
Other
- Female patients who are currently in pregnancy or are willing to be pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UOC Ematologia ASST dei Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.