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Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv15
  2. Primary completion date: Mar 2026 to Mar 2028 Completion date: Jun 2026 to Jun 2028v14 Show 1 more changeShow less
    • Completion date: Jun 2026 to Jun 2028
  3. Primary completion date: Feb 2025 to Mar 2026 Completion date: May 2025 to Jun 2026v13 Show 1 more changeShow less
    • Completion date: May 2025 to Jun 2026
  4. 3 versions Re-verified since Jan 23, 2024, no change to tracked fieldsv10-v12
  5. Primary completion date: Jun 2023 to Feb 2025 Completion date: Sep 2024 to May 2025v9 Show 1 more changeShow less
    • Completion date: Sep 2024 to May 2025
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria expanded, about 4 wordsv7 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv6
  4. Start date changed from estimate of Feb 2021 to Jan 27, 2021v5
  5. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  6. Start date: Jun 2020 to Feb 2021v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT). Stem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections.
Trial Details
NCT Number NCT04230356
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Hoxworth Blood Center
Conditions Allogeneic Stell Cell Transplant, Viral Infection
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov