Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Utah
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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;
- ✕ Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication).
Where it's recruiting
Salt Lake City
Source: ClinicalTrials.gov · NCT05183854 · last updated 2026-04-09