Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05183854

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

Led by University of Utah · Updated on 2026-04-09

61

Participants Needed

1

Research Sites

330 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to the 2018 International Workshop on CLL
  • Male or female aged 18 years or older
  • For naive cohort: No prior therapy for CLL
  • For venetoclax-treatment cohort: Received venetoclax for at least 12 months with last dose within 12 months prior to registration
Not Eligible

You will not qualify if you...

  • History of severe allergic reaction to prior pneumococcal vaccination
  • Received PCV13 or PCV20 pneumococcal vaccination in the last five years
  • Active infection requiring systemic antibiotic therapy
  • Use of immunosuppressive medication within 14 days before study start, except for permitted steroids (intranasal, inhaled, topical, eye drops, local injection, or physiologic doses ≤10 mg/day prednisone equivalent)
  • Concurrent illness or condition that may negatively affect study participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

D

David Samuel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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