RecruitingPhase 2NCT04230356

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

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


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

180 participants

Start Date

Jan 27, 2021

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving donor immune cells (called virus-specific T cells, or VSTs) on a set schedule — before any viral infection develops — is better than waiting until a viral infection occurs after a bone marrow/stem cell transplant. **You may be eligible if...** - You have recently received a bone marrow or stem cell transplant (at least 21 days ago) - Your overall health is stable enough to receive the VST infusion - You are not on high doses of steroids - OR, in the treatment arm, you have a detected viral infection (adenovirus, CMV, EBV, or BK virus) above a certain threshold level in your blood **You may NOT be eligible if...** - You have active severe graft-versus-host disease (GVHD, a complication where donor cells attack the recipient's body) - Your original cancer is relapsing in an uncontrolled way - You received certain immune-suppressing antibody treatments (ATG or alemtuzumab) very recently - Your condition is too critical to safely receive the infusion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT04230356


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