RECRUITING

Third Party Viral Specific T-cells (VSTs)

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Conditions

Viral InfectionViral ReactivationInfection in an Immunocompromised HostEpstein-Barr Virus (EBV)Adenovirus (ADV)Cytomegalovirus (CMV)T-CellsDonorBK virus (BKV)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.

Official Title

Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients

Quick Facts

Study Start:2015-09-02
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02532452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Immunocompromised patient with evidence of viral infection or reactivation
  2. * Age \>1 day
  3. * Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
  4. * Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
  5. * Must be able to receive CTL infusion in Cincinnati
  6. * Informed consent obtained by PI or sub-investigator either in person or by phone
  1. * Active acute GVHD grades II-IV
  2. * Uncontrolled bacterial or fungal infection
  3. * Uncontrolled relapse of malignancy requiring treatment with chemotherapy
  4. * Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
  5. * Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days

Contacts and Locations

Study Contact

Jamie Wilhelm
CONTACT
(513) 803-1102
Jamie.Wilhelm@cchmc.org
Michael Grimley, MD
CONTACT
Michael.Grimley@cchmc.org

Principal Investigator

Michael Grimley, MD, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Akron Children's Hospital
Akron, Ohio, 44308
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Michael Grimley, MD, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09-02
Study Completion Date2027-12

Study Record Updates

Study Start Date2015-09-02
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Epstein-Barr Virus (EBV)
  • Adenovirus (ADV)
  • Cytomegalovirus (CMV)
  • T-Cells
  • Donor
  • BK virus (BKV)

Additional Relevant MeSH Terms

  • Viral Infection
  • Viral Reactivation
  • Infection in an Immunocompromised Host