RECRUITING

Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Comparative Study of Anti-Pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Quick Facts

Study Start:2023-09-29
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05417165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women \>= 18 years of age
  2. * 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
  3. * Treatment naive CLL/SLL; No prior therapy for CLL/SLL, including chemotherapy and/or radiotherapy is allowed
  4. * Estimated life expectancy of greater than 24 months
  1. * Patients with neutropenic (granulocyte \[PMN\]s \< 500 cells/mm\^3) or having received rituximab within 6 months
  2. * Patients with fever (temperature \> 38 degrees Celsius \[C\]) within 1 week
  3. * Active infection, recent infection requiring systemic treatment that was completed =\< 14 days before starting treatment on the study
  4. * Patients with known human immunodeficiency virus (HIV) infection
  5. * History of allergic reactions attributable to compounds of similar chemical or biologic composition to any component of pneumococcal vaccines
  6. * Chemotherapy in 4 weeks or received Rituximab or similar anti CD20 monoclonal antibody for non-hematological indications within 6 months
  7. * Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination
  8. * History of allogenic stem cell transplantation
  9. * Patients who have received cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
  10. * Patients who have previously received pneumococcal vaccine within the preceding 12 months
  11. * Absolute lymphocyte count less than 500 cells/mm\^3
  12. * Patient with other severe immune deficiency
  13. * Patients may not be receiving any other investigational agents
  14. * Active malignancy from which the subject is considered by his or her physician to have a less than 5-year survival expectation
  15. * 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
  16. * 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
  17. * 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
  18. * Unwilling or unable to participate in all required study evaluations and procedures
  19. * 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)

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Seema A Bhat, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Seema Bhat

  • Seema A Bhat, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-09-29
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma