Chronic Lymphocytic LeukemiaNCT06364033
Biological and Clinical Efficacy of Shingrix in Patients With CLL
A study testing serologic response evaluation in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL-like MBL
- What is being tested?
- serologic response evaluation
- How many people
- 312 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL-like MBL, Varicella-zoster Virus Reactivation
- Being tested
- serologic response evaluation
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serologic response evaluationBiological
Blood samples collection
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Coscia, Principal investigator, UOC Ematologia ASST Sette Laghi Varese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364033
- Sponsor's protocol ID
- CLL2624
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT06364033
- Acronym / sponsor ID
- CLL2624
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL-like MBL, Varicella-zoster Virus Reactivation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serologic response evaluationBlood samples collection | Biological | – |
Primary outcome
Serologic response evaluation
Time frame: at 1 month
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Coscia principal investigator
UOC Ematologia ASST Sette Laghi Varese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serologic response evaluation in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serologic response evaluation (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.