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NCT02048332 · ClinicalTrials.gov registry record · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
A Phase 1 study of Viral Infection and Allogeneic Stem Cell Transplant, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 750
- Enrollment target
- 3
- Study locations
NCT02048332 is a Phase 1 study of Viral Infection and Allogeneic Stem Cell Transplant that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 750 participants, above the 161-participant average among 11 other Viral Infection trials with a reported enrollment target (366% higher). The trial reports 3 study locations across 1 state.
The verdict
NCT02048332, a Phase 1 study of Viral Infection and Allogeneic Stem Cell Transplant, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 750 participants
- Enrollment target
- 3
- Study locations
Study Summary
In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. 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 an easier way to treat these infections.
Conditions Studied
Interventions
- BIOLOGICAL Viral specific VST Infusion
Study Locations (3)
Ohio
- Akron Children's Hospital - Akron
- University of Cincinnati Medical Center - Cincinnati
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02048332
The ClinicalTrials.gov registry entry for NCT02048332 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 750 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 161-participant average among 11 other Viral Infection trials with a reported enrollment target (366% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Viral Infection appearing as the primary indexed condition, and to 1 intervention - of which Viral specific VST Infusion is the first listed.
NCT02048332 reports 3 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02048332 about?
NCT02048332 is a clinical study titled "Donor-Derived Viral Specific T-cells (VSTs)". In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infec...
What is the current status of trial NCT02048332?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 750 participants. The study started on 2014-02-05. Estimated completion is 2027-01.
What conditions does trial NCT02048332 study?
This clinical trial studies the following conditions: Viral Infection, Allogeneic Stem Cell Transplant, Viral Reactivation.
What interventions are being tested in trial NCT02048332?
The interventions under investigation include: Viral specific VST Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02048332?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02048332 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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