RecruitingPhase 2NCT05417165

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Phase II Comparative Study of Anti-Pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Sponsor

Seema Bhat

Enrollment

80 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Summary

This phase II trial compares the effect of initial vaccination (PCV20 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with chronic lymphocytic leukemia. At present chronic lymphocytic leukemia patients are poorly protected by anti-pneumococcal vaccination. Current vaccination schedule for chronic lymphocytic leukemia patients is based on general recommendations in immunocompromised patients (initial vaccination with PCV13 followed by one dose of PSV23 after an interval of two months, followed by revaccination at 5 years). Giving patients frequent immunization as compared to 5 year immunization may result in higher protective titers in patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the best vaccination strategy against pneumonia-causing bacteria for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). People with these blood cancers have weakened immune systems, which makes them more vulnerable to certain infections. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CLL or SLL (confirmed by lab testing) - You have not yet received any treatment for your CLL/SLL - You have adequate organ function **You may NOT be eligible if...** - You have previously received treatment for CLL or SLL - You have received a pneumococcal vaccine in the past 5 years - You have an active infection or another serious illness - You are on immunosuppressive medications - You are pregnant or breastfeeding - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPneumococcal 20-valent Conjugate Vaccine

Given IM

BIOLOGICALPneumococcal Polyvalent Vaccine

Given IM

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05417165

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