Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSeattle Children's Hospital
About this trial
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Enrolled in an SCTx GTP clinical trial;
Received or planned to receive an SCTx GTP;
Subject and/or legally authorized representative have provided consent/assent for study participation.
Disqualifiers
None
Trial population
Patients who have received treatment with a gene therapy product on an SCTx Sponsored clinical trial.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Long term follow up in all patients who received an SCTx gene therapy product
Other interventionParticipants will be followed for 15 years following the receipt of their final infusion on a separate SCTx gene therapy protocol to monitor for the long term effects of CAR T cell therapy
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of delayed adverse events
The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.
Time frame
15 years post-final infusion of SCTx GTP2
Long-term persistence of SCTx Gene Therapy Products
Monitor for long-term persistence of SCTx GTPs.
Time frame
15 years post-final infusion3
Long-term clinical outcomes following treatment with SCTx GTP
Death from any cause and first relapse following an initial remission
Time frame
15 years post-final infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov