RECRUITING

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

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Conditions

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Study of the Efficacy of the Pneumococcal Pneumonia Vaccine Series in Patients With Chronic Lymphocytic Leukemia Associated Immunodeficiency (PROTECT CLL)

Quick Facts

Study Start:2022-01-07
Study Completion:2027-01-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05183854

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * NAIVE COHORT: Male or female subject aged \>= 18 years.
  3. * NAIVE COHORT: Subjects must not have received prior therapy for CLL.
  4. * 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.
  5. * VENETOCLAX-TREATMENT COHORT: Subjects must have received venetoclax (any dose) for at least 12 months with the last dose =\< 12 months prior to registration.
  1. * Subjects who have experienced a severe allergic reaction to prior pneumococcal vaccination.
  2. * Subjects who have received a PCV13 or PCV20 pneumococcal vaccination in the last five years.
  3. * If they have received PPSV23 in ≥ 1 year and no other pneumococcal vaccine they may be included.
  4. * Active infection requiring systemic antibiotic therapy.
  5. * Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
  6. * Intranasal, inhaled, topical steroids, eye drops or local steroid injection (e.g., intra-articular injection);
  7. * Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent;
  8. * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography \[CT\] scan premedication).
  9. * Concurrent illness or condition, which, in the opinion of the treating investigator, would negatively impact the subject's study participation.

Contacts and Locations

Study Contact

Catherine Cromar
CONTACT
801-213-5652
catherine.cromar@hci.utah.edu

Principal Investigator

Daniel Ermann, MD
PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Daniel Ermann, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-07
Study Completion Date2027-01-07

Study Record Updates

Study Start Date2022-01-07
Study Completion Date2027-01-07

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma