What side effects are associated with this type of intervention?

Common treatments for lymphoma that involve immune system stimulation, such as vaccines and immunotherapies, can have a range of side effects. For example, sipuleucel-T, an immunotherapy, commonly causes mild side effects like chills, fatigue, fever, back pain, nausea, joint ache, and headache, with serious adverse events being rare. Rituximab, another immunotherapy, can cause side effects such as infusion reactions, fever, and chills. Vaccines like PCV20, which stimulate the immune system, generally have mild side effects including injection site pain, swelling, and fever. Serious adverse events are rare but can include severe allergic reactions.

What prior FDA approvals exist?

FDA-approved treatments for lymphoma that involve immune system modulation include anti-CD20 therapies such as rituximab, obinutuzumab, and ofatumumab. These drugs target the CD20 antigen on B cells, leading to their destruction and aiding in the management of B-cell lymphomas. While the PCV20 vaccine is being studied for its immunogenic effects in lymphoma survivors, similar immune-stimulating treatments have not been specifically mentioned in the context of lymphoma FDA approvals.

What other types of research exist?

Promising alternatives to PCV20 for Lymphoma patients include the 13-valent pneumococcal conjugate vaccine (PCV13), which has shown efficacy in various immunocompromised populations, including CLL patients and elderly adults. Additionally, the 15-valent pneumococcal conjugate vaccine (PCV15) is being evaluated in clinical trials and may offer broader protection. Both PCV13 and PCV15 have demonstrated good safety and immunogenicity profiles in relevant studies.

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Cancer Vaccine

PCV20 Vaccine for Lymphoma Survivors

Phase 4

Recruiting

Led By Fareed Khawaja, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma

Patients who are at least 18 years of age

Must not have

Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment

Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a vaccine called PCV20 to protect against pneumonia in patients who had B cell lymphoma and were treated with anti-CD20 therapy. The vaccine helps the immune system produce antibodies to fight off the bacteria causing pneumonia. PCV20 was developed to expand protection against pneumococcal disease beyond the previous vaccine by including additional components.

Who is the study for?

This trial is for adults over 18 who've had B-cell non-Hodgkin lymphoma, are in remission for at least a year, and have previously been treated with anti-CD20 therapy. They must be able to consent themselves and commit to follow-up appointments. Those vaccinated against pneumococcus within the last 5 years or who've had certain cell therapies can't join.

What is being tested?

The study tests the PCV20 vaccine's effectiveness in two ways: one group gets a single dose, while another receives an additional booster shot. The goal is to see which method better stimulates immunity in lymphoma survivors treated with anti-CD20 therapy.

What are the potential side effects?

Potential side effects of the PCV20 vaccine may include pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, chills or mild fever. These reactions are generally short-lived.

Eligibility Criteria

Inclusion Criteria

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

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I have received anti-CD20 therapy for my B-cell lymphoma.

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I am 18 years old or older.

Exclusion Criteria

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

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I have received a pneumonia vaccine in the last 5 years.

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I have undergone cellular therapy, such as CAR T-cell therapy or a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Side effects data

From 2023 Phase 3 trial • 2663 Patients • NCT05425732

74%

Injection site pain

34%

Fatigue

26%

Headache

14%

Injection site swelling

14%

Myalgia

13%

Injection site erythema

Cellulitis

Lower limb fracture

Jejunal perforation

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: PCV20

Cohort 2: V116

Cohort 1: PCV20

Cohort 1: V116

Unplanned Participants

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm Group B (PCV20)Experimental Treatment1 Intervention

Participants will receive 2 doses of the vaccine

Group II: Arm Group A (PCV20)Experimental Treatment1 Intervention

Participants will receive 1 dose of the vaccine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PCV20

2023

Completed Phase 3

~3780

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphoma include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while immunotherapy, such as anti-CD20 therapy, stimulates the immune system to recognize and destroy cancer cells. Targeted therapies, like bispecific antibodies, bind to specific proteins on cancer cells to facilitate their destruction by the immune system. These mechanisms are crucial for lymphoma patients as they offer multiple strategies to combat the disease, potentially leading to better outcomes and fewer side effects compared to traditional treatments.

A Comparative and Comprehensive Review of Antibody Applications in the Treatment of Lung Disease.Combinatorial therapy of immune checkpoint and cancer pathways provides a novel perspective on ovarian cancer treatment.Current therapeutic strategies for advanced pancreatic cancer: A review for clinicians.