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New treatment option for Chronic Lymphocytic Leukemia
Official title Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05417165
What this study is testing
What is Pneumococcal 20-valent Conjugate Vaccine?
Pneumococcal 20-valent Conjugate Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as PCV 20, PCV 20 Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.