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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049134
• Other study ID #: 2023-0590
• Secondary ID: NCI-2023-07264
• Status: Recruiting
• Phase: Phase 4
• Start date: October 6, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Fareed Khawaja, MD
• Phone: (281) 610-0253
• Email: fkhawaja[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of a pneumococcal vaccine called PCV20 when given as a single dose versus a boosted regimen to patients who previously received anti-CD20 therapy as treatment for B cell lymphoma.

Description:

Primary Objectives:

--Compare the humoral responses in terms of difference in IgG titers at 1 month from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.

Secondary Objectives:

• Compare the humoral responses in terms of difference in IgG titers at 3, 6 and12 from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.

• Estimate the rate of pneumonia (all bacterial pneumonia including pneumococcal pneumonia) within a year from routine single dose PCV20 or a boosted PCV20 regimen in lymphoma survivors who previously received treatment with anti-CD 20 therapy.

• Correlate humoral responses to development of bacterial pneumonia and pneumococcal pneumonia and with severity of this infection in lymphoma survivors within a year of vaccination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• PCV20
Given by Injection into the muscle

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center