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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05713214
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Hematologic Malignancy
  • Relapsed Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Feb 8, 2023
Status verified
May 2026
Primary completion
Dec 1, 2052
Completion
Dec 1, 2052

Study Design

Enrollment
1,000 participants (estimated)

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

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Aimee Talleur, MD
[email protected]
866-278-5833
Aimee Talleur, MD (PRINCIPAL_INVESTIGATOR)

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St. Jude Children's Research Hospital· Memphis, TN

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