This study is designed to collect long-term safety and survival data from participants previously treated in an eligible Century-sponsored index trial. This is an observational study, and the elements of the study design allow for important follow-up for safety, survival, and the continued evaluation of any late adverse events (AEs) that may appear after treatment with such cellular products. Additionally, collection of persistence data from participants will support the identification of any long-term risks or late AEs that may be causally related to treatment with such cellular products.
Study Type
OBSERVATIONAL
Enrollment
375
As this is a non-interventional rollover, long-term safety follow-up study, no intervention will be administered.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
NOT_YET_RECRUITINGUniversity of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States
NOT_YET_RECRUITINGUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGCorewell Health
Grand Rapids, Michigan, United States
NOT_YET_RECRUITINGLevine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGUniversity of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITINGSwedish Cancer Institute
Seattle, Washington, United States
RECRUITINGNumber of Participants With any Adverse Events of Special Interest (AESI)
Time frame: Up to 180 months
Number of Participants With Cellular Product-related Serious Adverse Events (SAEs)
Time frame: Up to 180 months
Overall Survival (OS)
OS is defined as the time from first treatment with a cellular therapy product in the index trial to date of death by any cause.
Time frame: From first dose of study drug up to end of the study or death whichever occurs first (up to 180 months)
Percentage of Participants With Persistent Product
Persistence of the cellular product will be assessed by a droplet digital polymerase chain reaction molecular test to evaluate transgene copies in the peripheral blood. Summary of persistence sample results (positive/negative) will be reported.
Time frame: Up to 180 months
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