Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Results posted: Oct 7, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints revised (5)
    • Primary endpoint revised
  2. Primary completion date: May 28, 2025 to Jul 31, 2025v20
  3. 2 versions Re-verified since Jun 17, 2025, no change to tracked fieldsv18-v19
  4. Primary completion date: Jun 9, 2025 to May 28, 2025v17
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Apr 2025 to Jun 9, 2025
    • Study completion date: Dec 2025 to Jun 2027
    • Site details revised
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Site contact updatedv15
  2. Primary completion date: Dec 2024 to Apr 2025v14
  3. Primary completion date: Aug 2024 to Dec 2024
    • Study completion date: Aug 2025 to Dec 2025
    v13
  4. Study completion date: May 2025 to Aug 2025v12
  5. Primary completion date: May 2024 to Aug 2024v11
  6. Primary completion date: Feb 2024 to May 2024
    • Study completion date: Feb 2025 to May 2025
    v10
  7. Site contact updatedv9
  8. Re-verified, no change to tracked fieldsv8
  9. Eligibility criteria expanded, about 2 wordsv7
  10. 2 versions Re-verified since May 31, 2022, no change to tracked fieldsv5-v6
  11. Start date: Feb 2, 2021 to Feb 18, 2021v4
  12. Re-verified, no change to tracked fieldsv3
  13. Primary endpoint revised
    • Secondary endpoints: 4 to 5
    • Eligibility criteria shortened, about 3 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to evaluate whether receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before and after CD19-targeted CAR T cell therapy will optimize cellular and humoral immunity to pneumococcus.
Trial Details
NCT Number NCT04745559
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Conditions
(from sponsor)		 Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), High-grade B-cell Lymphoma (HGBCL), Follicular Lymphoma
Related terms Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
Enrollment 26 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov