CAR T Cell, CAR T Cell Therapy
Conditions
Brief summary
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.
Interventions
OTHERLong term follow up in all patients who received an SCTx gene therapy product
Participants 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
Sponsors
Seattle Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Enrolled in an SCTx GTP clinical trial; 2. Received or planned to receive an SCTx GTP; 3. Subject and/or legally authorized representative have provided consent/assent for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delayed adverse events | 15 years post-final infusion of SCTx GTP | The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received. |
| Long-term persistence of SCTx Gene Therapy Products | 15 years post-final infusion | Monitor for long-term persistence of SCTx GTPs. |
| Long-term clinical outcomes following treatment with SCTx GTP | 15 years post-final infusion | Death from any cause and first relapse following an initial remission |
Countries
United States
Contacts
CONTACTAdam Lamble
Outcome results
None listed