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Recruiting Phase 2 NCT05417165

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Trial Parameters

Condition Chronic Lymphocytic Leukemia
Sponsor Seema Bhat
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-09-29
Completion 2026-10-31
Interventions
Pneumococcal 20-valent Conjugate VaccinePneumococcal Polyvalent Vaccine

Brief 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 Criteria

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 * Chemoth

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