Vaccination for Pneumonia in Patients with Chronic Lymphocytic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Huntsman Cancer Institute/University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Daniel Ermann, MD — Huntsman Cancer Institute
• Study coordinator: David Samuel
• Email: david.samuel@hci.utah.edu
• Phone: 801-587-4713

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Venetoclax plus Zanubrutinib for CLL/SLL in frontline or previously treated patients

  This phase II trial tests if venetoclax plus zanubrutinib can safely and effectively treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma, including those who are newly diagnosed and those who have had prior therapy.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07734038

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

• NX-5948 plus other medicines for B-cell cancers

  This trial tests NX-5948 in combination with venetoclax, with or without anti-CD20 antibodies, for adults with CLL/SLL or B-cell lymphoma that has returned or worsened or is newly diagnosed but needing treatment.

  Recruiting at 5 sites Phase 1/2 Nurix Therapeutics, Inc. · Aurora, Colorado and 8 other locations · NCT07520006

• NX-5948 vs Pirtobrutinib in R/R CLL/SLL

  This study tests NX-5948 against pirtobrutinib in people with relapsed or refractory CLL/SLL who have previously tried a covalent BTK inhibitor.

  Recruiting at 6 sites Phase 3 Nurix Therapeutics, Inc. · Macon, Georgia and 5 other locations · NCT07516093

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.