Chronic Lymphocytic Leukemia Clinical Trial
Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
Summary
This phase II trial compares the effect of initial vaccination (PCV13 followed by PSV23) with yearly vaccinations of PSV23 to the standard 5 year vaccination in patients with leukemia-cll/" >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.
Full 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, 19A 19 F and 23F using the enzyme-linked immunosorbent assay [ELISA] method).
SECONDARY OBJECTIVES:
I. Number of patients with anti-pneumococcal immunogenicity at 5 years. II. Number of patients with local and/or general reaction at months 1, 3 as self-reported.
III. Number of pneumococcal infections.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive PCV 20 IM at week 0. Titers will be checked 4 weeks after this dose. Booster Vaccine: None. Titers will be checked at 12 weeks and then yearly for 5 years.
ARM B: Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: None. Annual titers will be checked for 5 years.
ARM C: Patients receive PCV 20 IM at week 0 and PSV23 IM at week 8. Titers will be checked 4 weeks after the first dose and at 12 weeks (4 weeks after the second dose). Booster Vaccine: PCV23 booster vaccination dose will be administered yearly for 5 years. Pre-vaccination and post-vaccination (at 4 weeks) titers will be checked each time yearly for 5 years.
Eligibility Criteria
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 5-year survival expectation
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)
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There is 1 Location for this study
Columbus Ohio, 43210, United States More Info
Principal Investigator
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