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Clinical trial

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

ID
Name
2023-0590
Description
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.
Trial arms
Trial start
2023-10-06
Estimated PCD
2025-07-31
Trial end
2027-07-31
Status
Recruiting
Phase
Early phase I
Treatment
PCV20
Given by Injection into the muscle
Arms:
Arm Group A (PCV20), Arm Group B (PCV20)
Size
30
Primary endpoint
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
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-16

1 organization

1 product

1 indication

Organization
M.D. Anderson Cancer Center
Product
PCV20
Indication
lymphoma