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Cancer Vaccine

Pneumonia Vaccines for CLL

Phase 2

Recruiting

Led By Daniel Ermann, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

NAIVE COHORT: Subjects must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to the 2018 International Workshop on CLL.

Must not have

Active infection requiring systemic antibiotic therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years post ppsv23 vaccination

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two different pneumococcal vaccines, given as a series, can help prevent pneumococcal infections in patients with chronic lymphocytic leukemia.

Who is the study for?

This trial is for adults aged 18+ with chronic lymphocytic leukemia who haven't had prior CLL treatment, or those treated with venetoclax for at least a year. Participants should not have used immunosuppressants recently, except certain steroids, and mustn't have had specific pneumonia vaccines in the last five years.

What is being tested?

The PROTECT CLL Trial is testing if a series of two pneumococcal vaccines (PCV20 and PPSV23) can effectively stimulate an immune response to prevent infections in patients with chronic lymphocytic leukemia.

What are the potential side effects?

Potential side effects from PCV20 and PPSV23 may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or rash. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with venetoclax for at least a year and my last dose was within the last 12 months.

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I have been diagnosed with CLL or SLL as per the 2018 guidelines.

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I have never received treatment for chronic lymphocytic leukemia.

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I have been diagnosed with CLL or SLL as per the 2018 guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post ppsv23 vaccination

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post ppsv23 vaccination

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post ppsv23 vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

Proportion of patients who maintain adequate immune response

+1 more

Other study objectives

Number of patients that contract pneumonia

Proportion of venetoclax treated chronic lymphocytic leukemia (CLL) patients who achieve a two-fold increase in antibody titers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (PCV20, PPPSV23)Experimental Treatment3 Interventions

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.

Group II: Arm I (PCV20, PPSV23)Experimental Treatment3 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pneumococcal 20-valent Conjugate Vaccine

2022

Completed Phase 2

~210

0 / 5Eligibility criteria met