NCT05417165RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Jun 2022
- Start date
- 29 Sept 2023
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Seema Bhat
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05417165
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 29 Sept 2023 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with neutropenic (granulocyte \[PMN\]s \< 500 cells/mm\^3) or having received rituximab within 6 months
- Active infection, recent infection requiring systemic treatment that was completed =\< 14 days before starting treatment on the study
- 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
- 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
- Patients may not be receiving any other investigational agents
- 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
Other illness
- 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
- History of allogenic stem cell transplantation
- 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
Lab values
- Absolute lymphocyte count less than 500 cells/mm\^3
Other
- Patients with fever (temperature \> 38 degrees Celsius \[C\]) within 1 week
- Patient with other severe immune deficiency
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.