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OpenTrials
Completed

NCT Number: NCT03883906

Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent 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 your 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 we are trying to find a way to prevent these infections.

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Key information

Conditions

Allogeneic Stem Cell Transplant Infections Viral Infection Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs
  • Active acute GVHD grades II-IV
  • Uncontrolled relapse of malignancy
  • Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. 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 prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.

Treatment and study plan

Viral Specific T-cells (VSTs)

Biological

VSTs will be infused into stem cell transplant recipients

Primary outcomes

  1. Number of Participants With Presence of a Toxicity

    Time frame: 30 days

    Participants will be assessed for the presence of a toxicity.

  2. Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)

    Time frame: 30 days

    Participants will be assessed for the presence of aGVHD.

Secondary outcomes

  1. Number of Participants With Presence of a Viral Infection

    Time frame: 30 days

    Participants will be assessed for the presence of viral infection.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Hoxworth Blood Center

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 21, 2019
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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