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.
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
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 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.
Blood adenovirus PCR ≥1,000
Parallel
Viral Specific T-cells (VSTs) Scheduled
Biological/VaccineVSTs will be infused into stem cell transplant recipients on schedule.
Viral Specific T-cells (VSTs) Treatment
Biological/VaccineVSTs will be infused into stem cell transplant recipients only if viremia is detected.
Number of Treatment Failures
Treatment failure is defined as EBV\>100,000, BKV \>100,000, CMV \>5,000 or Adv \>50,000 at any time post randomization.
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Children's Hospital Medical Center, Cincinnati
Lead sponsor
Hoxworth Blood Center
Collaborator
