Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia

Korábbi kezelés

• 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

Más betegség

• 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

Laborértékek

• Absolute lymphocyte count less than 500 cells/mm\^3

Egyéb

• 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)

• 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