Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Viral Specific T-cells (VSTs) Scheduled
  • Viral Specific T-cells (VSTs) Treatment

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators