Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leu… (NCT05183854) | Clinical Trial Compass
RecruitingPhase 2
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
United States61 participantsStarted 2022-01-31
Plain-language summary
This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV20 and PPSV23 are both vaccines that protect against bacteria that cause pneumococcal disease. Giving these vaccinations as series may make a stronger immune response and prevent against pneumococcal infections in patients with chronic lymphocytic leukemia. This is a single-center trial, conducted at Huntsman Cancer Institute.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
* NAIVE COHORT: Male or female subject aged \>= 18 years.
* NAIVE COHORT: Subjects must not have received prior therapy for CLL.
* VENETOCLAX-TREATMENT COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL.
* VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to registration.
Exclusion Criteria:
* Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
* Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
* If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
* Active infection requiring systemic antibiotic therapy.
* Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
* Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
* Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent;
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What they're measuring
1
Proportion of patients who achieve the protocol defined change in antibody titers
Timeframe: At 30 and 90 days post-PCV20 vaccination