Lymphoma
Conditions
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.
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. * 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.
Interventions
BIOLOGICALPCV20
Given by Injection into the muscle
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFareed Khawaja, MD
M.D. Anderson Cancer Center
Outcome results
None listed