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

NCT05713214 | Recruiting DMC

• 1 other identifier: LONGENE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.

  Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.

  30 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who have received genetically modified cell therapy products on St. Jude investigator-initiated clinical studies.

You may qualify if:

• Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.

You may not qualify if:

• Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample procurement.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Aimee Talleur, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimee Talleur, MD

CONTACT

866-278-5833; referralinfo@stjude.org

Swati Naik, MBBS

CONTACT

swati.naik@stjude.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 6, 2023
• Study Start: February 8, 2023
• Primary Completion (Estimated): December 1, 2052
• Study Completion (Estimated): December 1, 2052
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (1)