Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)

What's the purpose of this trial?

This phase II trial tests whether the pneumococcal pneumonia vaccine series (PCV13 and PPSV23) works to mount an effective immune response in patients with chronic lymphocytic leukemia. PCV13 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 trial is currently open and accepting patients.


What will happen during the trial?

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Additional Trial Information

Phase 2

Enrollment: 60 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

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 pneumonia vaccination.
* Subjects who have received a pneumococcal vaccination in the last five years.
* Active infection requiring topical or systemic 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.
Interested in this trial?
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