Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05713214

Conditions

Relapsed Hematologic Malignancy

Refractory Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05713214

Start date

Feb 8, 2023

Status verified date

Jun, 2026

Completion date

Dec 1, 2052

Anticipated

Primary completion date

Dec 1, 2052

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial. [ Time Frame: 30 years ]

Central Contacts and Locations

Central contacts

Aimee Talleur, MD

866-278-5833referralinfo@stjude.org

Swati Naik, MBBS

swati.naik@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Aimee Talleur, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Aimee Talleur, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-06-17.