Status:
RECRUITING
Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 PPSV...
Detailed Description
PRIMARY OBJECTIVE: I. To investigate the proportion of chronic lymphocytic leukemia (CLL) patients who mount an effective immune response to streptococcus pneumonia after receiving both pneumococcal ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 7 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05183854
Start Date
January 31 2022
End Date
January 7 2028
Last Update
February 21 2025
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112