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

Phase 2

Completed

• Conditions: Allogeneic Stem Cell Transplant; Viral Infection
• Interventions: Biological: Viral Specific T-cells (VSTs)

• Registration Number: NCT03883906
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-16
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Primary Completion: 2020-10-31
• Study Completion: 2021-10-01
• Results First Submitted: 2021-10-12
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-20
• Last Update Submitted: 2022-11-20
• Results First Posted: 2022-12-13
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viral Specific T-cells (VSTs)	Viral Specific T-cells (VSTs)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)	30 days	Participants will be assessed for the presence of aGVHD.
Number of Participants With Presence of a Toxicity	30 days	Participants will be assessed for the presence of a toxicity.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Presence of a Viral Infection	30 days	Participants will be assessed for the presence of viral infection.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States