Effects of a pneumococcal vaccine in lymphoma survivors after anti-CD20 therapy

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

This study is testing whether lymphoma survivors who had anti-CD20 therapy respond better to a single dose of a new pneumonia vaccine or a boosted version, to see how well it protects them from pneumonia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Drugs / interventions: chimeric antigen receptor
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06049134 on ClinicalTrials.gov

What this trial studies

This study compares the immune responses of lymphoma survivors who received anti-CD20 therapy when given a single dose of the 20-valent pneumococcal conjugate vaccine (PCV20) versus a boosted regimen. The primary objective is to measure the difference in IgG antibody levels one month after vaccination, while secondary objectives include assessing IgG levels at three, six, and twelve months, as well as the rate of pneumonia within a year following vaccination. The study aims to correlate immune responses with the incidence and severity of bacterial pneumonia in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have a history of non-Hodgkin B-cell lymphoma in remission for at least one year and have received anti-CD20 therapy.

Not a fit: Patients who have undergone cellular therapy, received pneumococcal vaccines within the last five years, or belong to vulnerable populations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the immune protection of lymphoma survivors against pneumonia, potentially reducing infection rates.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies have shown promising results in enhancing vaccine responses in immunocompromised individuals.

Eligibility criteria

Inclusion Criteria:

1. Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year.
2. Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma.
3. Patients who are at least 18 years of age.
4. Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf.

Exclusion Criteria:

1. Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation.
2. Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment.
3. Patients who are unable to attend follow-up appointments at designated times at MD Anderson.
4. Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)

Where this trial is running

Houston, Texas

• M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Fareed Khawaja, MD — M.D. Anderson Cancer Center
• Study coordinator: Fareed Khawaja, MD

Conditions Lymphoma