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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial compares how a pneumococcal vaccine works for people with B cell lymphoma who had anti-CD20 therapy.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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

2022

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,444 Total Patients Enrolled

253 Trials studying Lymphoma

32,512 Patients Enrolled for Lymphoma

Fareed Khawaja, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide information on the safety of Arm Group A (PCV20) for participants?

"The safety of Arm Group A (PCV20) was rated a 3, indicating that it is an approved treatment after multiple phases of trials."

Answered by AI

Are there any active openings for participants in this trial?

"Inaccordance with the clinicaltrials.gov data, this trial is not presently enrolling applicants. The medical experiment was initially uploaded on March 31st 2024 and last modified on September 20th of 2023. Although no recruitment is occurring right now, 1720 other trials are searching for participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy

2023. "Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06049134.