This phase IV trial compares the effect of a pneumococcal vaccine called PCV20 when given as a single dose versus a boosted regimen to patients who previously received anti-CD20 therapy for B-cell lymphoma. Pneumococcal vaccines are used to help prevent infections caused by a bacteria called Streptococcus pneumoniae. Information learned from this trial may help doctors determine the best dose of the PCV20 vaccine for patients with B-cell lymphoma who received anti-CD20 therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT06049134.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Fareed Khawaja
Phone: 281-610-0253
PRIMARY OBJECTIVE:
I. To compare the humoral responses in terms of difference in immunoglobulin G (IgG) titers at 1 month from routine single dose pneumococcal 20-valent conjugate vaccine (PCV20) or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.
SECONDARY OBJECTIVES:
I. Compare the humoral responses in terms of difference in IgG titers at 3, 6 and 12 from routine single dose PCV20 or a boosted PCV20 regimen in B cell lymphoma survivors who previously received treatment with anti-CD20 therapy.
II. 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-CD20 therapy.
III. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a single dose of PCV20 intramuscularly (IM) on day 0. Patients also undergo blood sample collection throughout the trail.
ARM II: Patients receive PCV20 IM on day 0 and at 1 month. Patients also undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFareed Khawaja
