About this trial

In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant.

The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death.

Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. 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 an easier 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 steroids to 0.5mg/kg prednisone or other steroid equivalent

Recipient must have achieved engraftment with ANC ≥ 500

Disqualifiers

Active acute GVHD grades II-IV

Uncontrolled bacterial or fungal infection

Uncontrolled relapse of malignancy requiring treatment with chemotherapy

Infusion of ATG or alemtuzumab within 2 weeks of VST infusion

Trial design

Treatments tested in this trial

  • Viral specific VST Infusion

Treatment groups

750 Participants
are divided into 1 treatment group

Locations

3
Akron Children's Hospital44308, AkronOhio, United States
Cincinnati Children's Hospital Medical Center45229, CincinnatiOhio, United States
University of Cincinnati Medical Center45219, CincinnatiOhio, United States

Sponsors and collaborators

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Hoxworth Blood Center

Collaborator