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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03883906
Collaborator
Hoxworth Blood Center (Other)
30
1
1
59.5
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Viral Specific T-cells (VSTs)
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Actual Study Start Date :
Mar 16, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Viral Specific T-cells (VSTs)

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of Toxicity [up to 30 days after last VST infusion]

    Participants will be assessed for the presence of a toxicity.

  2. Incidence of acute Graft-Vs-Host Disease (aGVHD) [up to 30 days after last VST infusion]

    Participants will be assessed for the presence of aGVHD.

Secondary Outcome Measures

  1. Incidence of viral infection [up to 30 days after last VST infusion]

    Participants will be assessed for the presence of viral infection.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229

Sponsors and Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • Hoxworth Blood Center

Investigators

  • Principal Investigator: Michael Grimley, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT03883906
Other Study ID Numbers:
  • 2019-0229
First Posted:
Mar 21, 2019
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2021