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Trial Title:
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
NCT ID:
NCT05713214
Condition:
Relapsed Hematologic Malignancy
Refractory Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
This is a prospective, longitudinal, non-therapeutic study which includes routine
assessment for long-term effects, as per FDA guidelines, after receipt of a gene therapy
product on a St. Jude investigator-initiated clinical trial. There will be no group
assignment, no use of placebo groups and no use of control subjects. Participants will
enroll on this long-term follow-up study after completion of necessary follow-ups on the
interventional clinical trial on which they received treatment with a genetically
modified product, to complete a total of 15 years of follow-up post infusion.
Assessments will include routine history, physical exam and blood sample procurement, in
accordance with FDA guidance, for 15 years post infusion of the gene therapy product.
Study evaluations may be performed by a local provider in conjunction with the St. Jude
research team. In addition, standard clinical data related to the subject's prior gene
therapy treatment will be reviewed. The data may include, but is not limited to: patient
demographics, disease history, on-going disease status updates, gene therapy product and
treatment characteristics, patient clinical status, post gene therapy disease directed
therapies, relapse and death
Criteria for eligibility:
Study pop:
All participants who have received genetically modified cell therapy products on St. Jude
investigator-initiated clinical studies.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Aimee Talleur, MD
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Investigator:
Last name:
Aimee Talleur, MD
Email:
Principal Investigator
Start date:
February 8, 2023
Completion date:
December 1, 2052
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713214
