Pneumococcal Pneumonia Vaccine Series (PCV20 and PPSV23) in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency, PROTECT CLL Trial

Phase 2RecruitingNCT05183854

University of Utah61 enrolled

Overview

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 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 is a single-center trial, conducted at Huntsman Cancer Institute.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of patients who achieve the protocol defined change in antibody titers

Will examine the proportion of patients who achieve the protocol defined change in antibody titers from baseline in at least 10 of 19 S.pneumoniae serotypes shared between pneumococcal 20-valent conjugate vaccine (PCV20) and pneumococcal polyvalent vaccine (PPSV23) at Study Visit 2 and 3. The observed proportion and an exact 95% binomial confidence interval will be reported. A one sample exact binomial test will be performed at one-sided alpha = 0.05. The null hypothesis is that the proportion is 50% or lower.

Time frame: At 30 and 90 days post-PCV20 vaccination

Secondary Outcomes

Proportion of patients who have a two-fold increase of immunoglobulin levels

Will examine the proportion of patients who have a two-fold increase of immunoglobulin levels from baseline at Study Visit 2 and 3 and do not develop pneumonia within five years post-PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported.

Time frame: Up to 5 years post- PPSV23 vaccination

Proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines

Will examine the proportion of vaccinated patients who have a two-fold increase in at least 10 of 19 S. pneumonia serotypes shared between PCV20 and PPSV23 vaccines and do not develop pneumonia within five years post PPSV23 vaccination. The observed proportion and an exact 95% binomial confidence interval will be reported.

Time frame: Up to 5 years post PPSV23 vaccination

Proportion of patients who have a two-fold increase in antibody titers to an individual serotype vaccination

Will examine the proportion of patients who have a two-fold increase in antibody titers to an individual serotype at Study Visit 2 and 3 post PPCV20 vaccination. The observed proportion and 95% exact binomial confidence intervals will be reported for each serotype.