Immunogenicity and Clinical Efficacy of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Lymphoma Survivors After Treatment With Anti-CD20 Therapy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed 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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm Group A (PCV20) Participants will receive 1 dose of the vaccine |
Biological: PCV20
Given by Injection into the muscle
|
| Experimental: Arm Group B (PCV20) Participants will receive 2 doses of the vaccine |
Biological: PCV20
Given by Injection into the muscle
|
Outcome Measures
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 [through study completion; an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients who have a history of non-Hodgkin B-cell lymphoma and whose disease has been in remission for at least 1 year.
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Patients who received any anti-CD20 therapy at any time during their treatment for B-cell lymphoma.
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Patients who are at least 18 years of age.
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Patients who can provide consent; no legal authorized representative will be able to provide consent on a patient's behalf.
Exclusion Criteria:
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Patients who have received cellular therapy, including chimeric antigen receptor T-cell therapy or any type of hematopoietic cell transplantation.
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Patients who have received PCV or pneumococcal polysaccharide vaccine within 5 years of screening for enrollment.
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Patients who are unable to attend follow-up appointments at designated times at MD Anderson.
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Any vulnerable population patient ((children, pregnant women, cognitively impaired adults, or prisoners)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Fareed Khawaja, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2023-0590
- NCI-2023-07264