Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeema Bhat
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pneumococcal 20-valent Conjugate Vaccine
- Pneumococcal Polyvalent Vaccine
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
Seema Bhat
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov