Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
NCT ID: NCT04230356
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2021-01-27
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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VSTs to Prevent
VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection.
Viral Specific T-cells (VSTs) Scheduled
VSTs will be infused into stem cell transplant recipients on schedule.
VSTs to Treat
VSTs will be given only if a viral infection develops.
Viral Specific T-cells (VSTs) Treatment
VSTs will be infused into stem cell transplant recipients only if viremia is detected.
Interventions
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Viral Specific T-cells (VSTs) Scheduled
VSTs will be infused into stem cell transplant recipients on schedule.
Viral Specific T-cells (VSTs) Treatment
VSTs will be infused into stem cell transplant recipients only if viremia is detected.
Eligibility Criteria
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Inclusion Criteria
* 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
* Blood CMV PCR ≥ 500
* Blood EBV PCR ≥ 9,000
* Plasma BKV PCR \>1,000
* Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
* Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
* Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
* Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.
* No active acute GVHD grades II-IV
* No uncontrolled relapse of malignancy
* No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
* Clinical status must allow tapering of any steroids to \< 0.5mg/kg prednisone or other steroid equivalent
Exclusion Criteria
* Uncontrolled relapse of malignancy.
* Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.
TREATMENT ARM
ALL
No
Sponsors
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Hoxworth Blood Center
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Stella Davies, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-1217
Identifier Type: -
Identifier Source: org_study_id
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