Status:
RECRUITING
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Seema Bhat
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 leuke...
Detailed Description
PRIMARY OBJECTIVE: I. Proportion of patients with anti-pneumococcal immunogenicity following early revaccination (1 year) at 2 years (Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Absolute lymphocyte count less than 500 cells/mm\^3
- Patient with other severe immune deficiency
- Patients may not be receiving any other investigational agents
- 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
- 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
- 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)
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05417165
Start Date
September 29 2023
End Date
October 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210