Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Seema Bhat
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Columbus
Source: ClinicalTrials.gov · NCT05417165 · last updated 2026-01-07