Pneumococcal Pneumonia Vaccine Series (PCV13 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial
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- STATUS
- Recruiting
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- End date
- Jan 7, 2027
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- participants needed
- 60
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- sponsor
- University of Utah
Summary
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.
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 13-valent conjugate vaccine (PCV13) and pneumococcal polyvalent vaccine (PPSV23) vaccinations. (Primary Analysis)
SECONDARY OBJECTIVES:
I. To improve the immunoglobulin levels and decrease the incidence of pneumonia in patients with CLL-associated immunodeficiency. (Primary Analysis) II. To evaluate the rate of decreased pneumonia as assessed by an immune response to streptococcus (S.) pneumoniae after PCV13 and PPSV23 series versus PCV13 alone. (Primary Analysis) III. To investigate the immune response to individual S. pneumoniae serotypes included in both the PCV13 and PPSV23 vaccinations. (Primary Analysis) IV. Evaluate the length of time an effective immune response is maintained, and if the recommendation of 5 years is adequate for CLL patients. (Primary Analysis)
EXPLORATORY OBJECTIVES:
I. Assess rate of pneumonia in CLL patients based on therapeutic strategy (i.e., BTKi, venetoclax, chemo-immunotherapy).
II. To evaluate the number of venetoclax treated CLL patients who mount an effective immune response to S. pneumoniae 30 days following both PCV13 and PPSV23 vaccinations. (Pilot Arm)
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I (PRIMARY ARM): Patients receive pneumococcal 13-valent conjugate vaccine intramuscularly (IM) on day 1 and pneumococcal polyvalent vaccine IM on day 60 in the absence of disease progression or unacceptable toxicity.
ARM II (PILOT ARM): Patients who have received or are receiving venetoclax therapy, receive pneumococcal 13-valent conjugate vaccine IM on day 1 and pneumococcal polyvalent vaccine IM on day 60 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 90 days and then every 6 months for 5 years.
Details
| Condition | Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma |
|---|---|
| Treatment | questionnaire administration, Pneumococcal 13-valent Conjugate Vaccine, Pneumococcal Polyvalent Vaccine, Pneumococcal Polyvalent Vaccine |
| Clinical Study Identifier | NCT05183854 |
| Sponsor | University of Utah |
| Last Modified on | 16 May 2022 |
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