Vaccination strategy for patients with chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of an enhanced vaccination schedule using PCV20 followed by PSV23 compared to the standard 5-year vaccination protocol in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The study aims to determine the proportion of patients achieving anti-pneumococcal immunogenicity after early revaccination at 2 years, as well as the incidence of pneumococcal infections and any adverse reactions. Patients will be randomized into different arms to receive varying vaccination schedules and their immune responses will be monitored over a 5-year period.

Why it matters

Who can join: the full rules

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
* 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)

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Seema A Bhat, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

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• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

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• Nemtabrutinib and venetoclax in untreated CLL/SLL

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• NX-5948 plus other medicines for B-cell cancers

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• NX-5948 vs Pirtobrutinib in R/R CLL/SLL

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• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.