RECRUITING

Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products

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

Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body. With this genetic modification comes risk of undesirable adverse events. Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that meet defined criteria. This protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a St. Jude initiated study.

Official Title

Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products

Quick Facts

Study Start:2023-02-08
Study Completion:2052-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05713214

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.
  1. * Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.

Contacts and Locations

Study Contact

Aimee Talleur, MD
CONTACT
866-278-5833
referralinfo@stjude.org
Swati Naik, MBBS
CONTACT
swati.naik@stjude.org

Principal Investigator

Aimee Talleur, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Aimee Talleur, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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 Date2023-02-08
Study Completion Date2052-12-01

Study Record Updates

Study Start Date2023-02-08
Study Completion Date2052-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsed Hematologic Malignancy
  • Refractory Hematologic Malignancy