Actively Recruiting
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-12
180
Participants Needed
1
Research Sites
383 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
H
Hoxworth Blood Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
- No critical illness making VST infusion hazardous
- Blood adenovirus PCR ≥1,000 (for treatment arm)
- Blood CMV PCR ≥ 500 (for treatment arm)
- Blood EBV PCR ≥ 9,000 (for treatment arm)
- Plasma BKV PCR >1,000 (for treatment arm)
- Evidence of invasive adenovirus infection (for treatment arm)
- Evidence of invasive CMV infection such as pneumonitis, retinitis, colitis, hepatitis (for treatment arm)
- Evidence of EBV-associated lymphoproliferation (EBV-LPD) proven or probable (for treatment arm)
- Evidence of symptomatic BK virus infection such as hemorrhagic cystitis or BK nephropathy (for treatment arm)
You will not qualify if you...
- Active acute GVHD grades II-IV
- Uncontrolled relapse of malignancy
- Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion
- Alemtuzumab levels must be ≤ 0.15 prior to infusion of VSTs; if higher, must be monitored until ≤ 0.15 for scheduled infusion eligibility
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
C
Celeste Dourson, MS
CONTACT
J
Jamie Wilhelm, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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