NCT05183854 Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
| NCT ID | NCT05183854 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Utah |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2022-01-31 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 61 participants in total. It began in 2022-01-31 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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; * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication). * Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.
Contact & Investigator
Daniel Ermann, MD
PRINCIPAL INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Frequently Asked Questions
Who can join the NCT05183854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05183854 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05183854 currently recruiting?
Yes, NCT05183854 is actively recruiting participants. Contact the research team at david.samuel@hci.utah.edu for enrollment information.
Where is the NCT05183854 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT05183854 clinical trial?
NCT05183854 is sponsored by University of Utah. The principal investigator is Daniel Ermann, MD at Huntsman Cancer Institute/ University of Utah. The trial plans to enroll 61 participants.
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