Back to resultsDonor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Primary Purpose
Allogeneic Stem Cell Transplant, Viral Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Viral Specific T-cells (VSTs)
Sponsored by
About this trial
This is an interventional prevention trial for Allogeneic Stem Cell Transplant
Eligibility Criteria
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.
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Viral Specific T-cells (VSTs)
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Presence of a Toxicity
Participants will be assessed for the presence of a toxicity.
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)
Participants will be assessed for the presence of aGVHD.
Secondary Outcome Measures
Number of Participants With Presence of a Viral Infection
Participants will be assessed for the presence of viral infection.
Full Information
NCT ID
NCT03883906
First Posted
March 19, 2019
Last Updated
November 20, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Hoxworth Blood Center
1. Study Identification
Unique Protocol Identification Number
NCT03883906
Brief Title
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Official Title
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Hoxworth Blood Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Stem Cell Transplant, Viral Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viral Specific T-cells (VSTs)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Viral Specific T-cells (VSTs)
Intervention Description
VSTs will be infused into stem cell transplant recipients
Primary Outcome Measure Information:
Title
Number of Participants With Presence of a Toxicity
Description
Participants will be assessed for the presence of a toxicity.
Time Frame
30 days
Title
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)
Description
Participants will be assessed for the presence of aGVHD.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Participants With Presence of a Viral Infection
Description
Participants will be assessed for the presence of viral infection.
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Grimley, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
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