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

Who is this study for? Patients with chronic lymphocytic leukemia associated immunodeficiency

What treatments are being studied? Pneumococcal 13-valent Conjugate Vaccine+Pneumococcal Polyvalent Vaccine

Status: Recruiting

Location: See location...

Intervention Type: Biological, Other

Study Type: Interventional

Study Phase: Phase 2

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Utah

Huntsman Cancer Institute/University of Utah

RECRUITING

Salt Lake City

Contact Information

Primary

Catherine Cromar

catherine.cromar@hci.utah.edu

801-213-5652

Time Frame

Start Date: 2022-01-31

Estimated Completion Date: 2028-01-07

Participants

Target number of participants: 60

Treatments

Experimental: Arm I (PCV20, PPSV23)

Patients receive pneumococcal 20-valent conjugate vaccine IM on day 1. PnumoVax23 will be given as an intramuscular injection on Visit 2 (approximately Day 75)

Experimental: Arm II (PCV20, PPPSV23)

Patients who have received or are receiving venetoclax therapy, receive pneumococcal 20-valent conjugate vaccine IM at study visit 1 and pneumococcal polyvalent vaccine IM at study visit 2 in the absence of disease progression or unacceptable toxicity.

Authors

Deborah M. Stephens

Related Therapeutic Areas

Chronic Lymphocytic Leukemia (CLL)

Pneumonia

Leukemia

Small Lymphocytic Lymphoma (SLL)

Chronic B-Cell Leukemia (CBCL)

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

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