A Randomized Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells (VSTs) for Control of Viral Infections After Allogeneic Stem Cell Transplant
Children's Hospital Medical Center, Cincinnati
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.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
SCHEDULED ARM: Inclusion Criteria: * 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 Exclusion Criteria: * Active acute GVHD grades II-IV. * 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…
Interventions
- BiologicalViral Specific T-cells (VSTs) Scheduled
VSTs will be infused into stem cell transplant recipients on schedule.
- BiologicalViral Specific T-cells (VSTs) Treatment
VSTs will be infused into stem cell transplant recipients only if viremia is detected.
Location
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio