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

Last updated: February 20, 2025
Sponsor: University of Utah
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Pneumonia

Chronic Lymphocytic Leukemia

Treatment

Pneumococcal 20-valent Conjugate Vaccine

Pneumococcal Polyvalent Vaccine

Questionnaire Administration

Clinical Study ID

NCT05183854
HCI145280
P30CA042014
HCI145280
NCI-2021-13373
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocyticleukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLLthroughout) 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 chroniclymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectivelyreferred to as CLL throughout) according to the 2018 International Workshop on CLL.

  • VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) forat least 12 months with the last dose =< 12 months prior to registration.

Exclusion

Exclusion Criteria:

  • Subjects who have experienced a severe allergic reaction to prior pneumococcalvaccination.

  • Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the lastfive years.

  • If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they maybe included.

  • Active infection requiring systemic antibiotic therapy.

  • Current or prior use of immunosuppressive medication within 14 days of cycle one dayone, 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 orequivalent;

  • Steroids as premedication for hypersensitivity reactions (e.g., computedtomography [CT] scan premedication).

  • Concurrent illness or condition, which, in the opinion of the treating investigator,would negatively impact the subject's study participation.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Pneumococcal 20-valent Conjugate Vaccine
Phase: 2
Study Start date:
January 31, 2022
Estimated Completion Date:
January 07, 2028

Study 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 20-valent conjugate vaccine (PCV20) 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 PCV20 and PPSV23 series versus PCV20 alone. (Primary Analysis) III. To investigate the immune response to individual S. pneumoniae serotypes included in both the PCV20 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 PCV20 and PPSV23 vaccinations. (Pilot Arm)

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I (PRIMARY ARM): Patients receive pneumococcal 20-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 20-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.

Connect with a study center

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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