RECRUITING

Donor-Derived Viral Specific T-cells (VSTs)

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

In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant. The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death. Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. 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 the investigators are trying to find an easier way to treat these infections.

Official Title

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

Quick Facts

Study Start:2014-02-05
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02048332

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:4 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recipient must be at least 21 days after stem cell infusion
  2. * Clinical status must allow tapering of steroids to 0.5mg/kg prednisone or other steroid equivalent
  3. * Recipient must have achieved engraftment with ANC ≥ 500
  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

Contacts and Locations

Study Contact

Jamie Wilhelm, BS
CONTACT
(513) 803-1102
Jamie.Wilhelm@cchmc.org

Principal Investigator

Michael Grimley, 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

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Michael Grimley, 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 Date2014-02-05
Study Completion Date2027-01

Study Record Updates

Study Start Date2014-02-05
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Epstein-Barr Virus (EBV)
  • Adenovirus (ADV)
  • t-cells
  • donor
  • transplant
  • children
  • cytomegalovirus (CMV)
  • BK virus (BKV)

Additional Relevant MeSH Terms

  • Allogeneic Stem Cell Transplant
  • Viral Infection
  • Viral Reactivation