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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04230356
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Allogeneic Stell Cell Transplant
  • Viral Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Viral Specific T-cells (VSTs) Scheduled — BIOLOGICAL
    VSTs will be infused into stem cell transplant recipients on schedule.
  • Viral Specific T-cells (VSTs) Treatment — BIOLOGICAL
    VSTs will be infused into stem cell transplant recipients only if viremia is detected.

Study Details

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.

Key Dates

Start date
Jan 27, 2021
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Experimental: VSTs to Treat
    VSTs will be given only if a viral infection develops.

Primary Outcome Measure

Number of Treatment Failures [ Time Frame: 21 - 100 days after transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Celeste Dourson, MS
[email protected]
513-636-7679
Stella Davies, MBBS, PhD (PRINCIPAL_INVESTIGATOR)

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Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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