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

Viral Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883906
• Other study ID #: 2019-0229
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplant
• Communicable Diseases
• Infections
• Viral Infection
• Virus Diseases

Intervention

Biological:
• Viral Specific T-cells (VSTs)
VSTs will be infused into stem cell transplant recipients

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Hoxworth Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Presence of a Toxicity	Participants will be assessed for the presence of a toxicity.	30 days
Primary	Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)	Participants will be assessed for the presence of aGVHD.	30 days
Secondary	Number of Participants With Presence of a Viral Infection	Participants will be assessed for the presence of viral infection.	30 days