Yearly shots could shield CLL patients from deadly infections
NCT ID NCT05417165
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving yearly pneumococcal vaccines to people with chronic lymphocytic leukemia (CLL) provides better protection than the standard vaccine given every 5 years. About 80 adults with untreated CLL will receive either the yearly schedule or the standard schedule. The goal is to see if more frequent vaccination boosts immune response and reduces infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women \>= 18 years of age * Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the World Health Organization (WHO) classification of hematopoietic neoplasms * Treatment naive CLL/SLL; No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed * Estimated life expectancy of greater than 24 months Exclusion Criteria: * Patients with neutropenic (granulocyte \[PMN\]s \< 500 cells/mm\^3) or having received rituximab within 6 months * Patients with fever (temperature \> 38 degrees Celsius \[C\]) within 1 week * Active infection, recent infection requiring systemic treatment that was completed =\< 14 days before starting treatment on the study * Patients with known human immunodeficiency virus (HIV) infection * History of allergic reactions attributable to compounds of similar chemical or biologic composition to any component of pneumococcal vaccines * Chemotherapy in 4 weeks or received Rituximab or similar anti CD20 monoclonal antibody for non-hematological indications within 6 months * Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination * History of allogenic stem cell transplantation * Patients who have received cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination * Patients who have previously received pneumococcal vaccine within the preceding 12 months * Absolute lymphocyte count less than 500 cells/mm\^3 * Patient with other severe immune deficiency * Patients may not be receiving any other investigational agents * Active malignancy from which the subject is considered by his or her physician to have a less than 24 month survival expectation. Non-melanoma skin cancer is not an exclusion criterion. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and/or psychiatric illness/social situations that would limit compliance with study requirements * Concurrent systemic immunosuppressant therapy (e.g., cyclosporine A, tacrolimus, etc., or chronic administration \[\> 14 days\] of \> 20 mg/day of prednisone) within 14 days of the first dose of study drug * Because of the potential for H2-blockers to modulate antibody response to pneumococcal vaccine, patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy * Unwilling or unable to participate in all required study evaluations and procedures * Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?