Vaccination for Pneumonia in Patients with Chronic Lymphocytic Leukemia
Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)
This study tests if a pneumonia vaccine can help boost the immune response in people with chronic lymphocytic leukemia and reduce their chances of getting pneumonia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05183854 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of the pneumococcal pneumonia vaccine series (PCV20 and PPSV23) in eliciting an immune response in patients diagnosed with chronic lymphocytic leukemia (CLL). The study aims to determine the proportion of patients who respond to the vaccines and to assess improvements in immunoglobulin levels and pneumonia incidence. Participants will be assigned to receive the vaccines and monitored for their immune response and pneumonia rates over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma who have not received prior therapy.
Not a fit: Patients who have experienced severe allergic reactions to pneumococcal vaccinations or have received certain pneumococcal vaccines in the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance immune protection against pneumonia in patients with chronic lymphocytic leukemia, potentially reducing infection rates.
How similar studies have performed: Other studies have shown promising results with pneumococcal vaccines in immunocompromised populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salt Lake City, Utah
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Ermann, MD — Huntsman Cancer Institute/ University of Utah
- Study coordinator: David Samuel
- Email: david.samuel@hci.utah.edu
- Phone: 801-587-4713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.