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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allogeneic Stem Cell Transplant, Viral Infection

Intervention / Treatment
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* Biological: Viral Specific T-cells (VSTs)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viral Specific T-cells (VSTs)<br> | Biological: Viral Specific T-cells (VSTs)<br>* VSTs will be infused into stem cell transplant recipients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Presence of a Toxicity | Participants will be assessed for the presence of a toxicity. | 30 days | 
| Number of Participants With Acute Graft-Vs-Host Disease (aGVHD) | Participants will be assessed for the presence of aGVHD. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Presence of a Viral Infection | Participants will be assessed for the presence of viral infection. | 30 days |