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NCT04230356 · ClinicalTrials.gov registry record · Phase 2
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
A Phase 2 study of Viral Infection and Allogeneic Stell Cell Transplant, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT04230356: Recruiting Phase 2 study of Viral Infection and Allogeneic Stell Cell Transplant, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04230356 is a Phase 2 study of Viral Infection and Allogeneic Stell Cell Transplant that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 180 participants, below the 213-participant average among 11 other Viral Infection trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04230356, a Phase 2 study of Viral Infection and Allogeneic Stell Cell Transplant, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Treatment failure is defined as EBV\>100,000, BKV \>100,000, CMV \>5,000 or Adv \>50,000 at any time post randomization.
Conditions Studied
Interventions
- BIOLOGICAL Viral Specific T-cells (VSTs) Scheduled
- BIOLOGICAL Viral Specific T-cells (VSTs) Treatment
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT04230356 shows while recruiting
NCT04230356 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 213-participant average among 11 other Viral Infection trials with a reported enrollment target (15% lower).
The record links to 2 conditions, with Viral Infection appearing as the primary indexed condition, and to 2 interventions - of which Viral Specific T-cells (VSTs) Scheduled is the first listed.
NCT04230356 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04230356 about?
NCT04230356 is a clinical study titled "Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant". 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 vi...
What is the current status of trial NCT04230356?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2021-01-27. Estimated completion is 2028-06.
What conditions does trial NCT04230356 study?
This clinical trial studies the following conditions: Viral Infection, Allogeneic Stell Cell Transplant.
What interventions are being tested in trial NCT04230356?
The interventions under investigation include: Viral Specific T-cells (VSTs) Scheduled (BIOLOGICAL), Viral Specific T-cells (VSTs) Treatment (BIOLOGICAL).
Who is sponsoring clinical trial NCT04230356?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04230356 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Viral Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04230356's enrollment target sits among peer trials
180 6th of 11 higher than 6 of 11 other Viral Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Viral Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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