The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies. The primary objectives of this study are to: * Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality) * Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.
Study Type
OBSERVATIONAL
Enrollment
1,500
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
No investigational product will be administered
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, and serious infections.
Time frame: Up to 15 years
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, and serious infections.
Time frame: Up to 15 years
Percentage of Participants With New Malignancies
New malignancies regardless of causality includes time to development of the new malignancy, type, location, staging, and molecular mechanism (including testing for presence of the CAR transgene and (replication-competent retrovirus/replication-competent lentivirus (RCR/RCL)). Also to assess the occurrence of all related SAEs that do not fall under the umbrella of targeted events.
Time frame: Up to 15 years
Percentage of Participants Experiencing Related SAEs
Adverse events which might be possibly related to the treatment drugs.
Time frame: Up to 15 years
Height of Pediatric and Adolescent Participants
Time frame: Up to 15 years
Weight of Pediatric and Adolescent Participants
Time frame: Up to 15 years
Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult.
Time frame: Up to 15 years
Time to Subsequent Anticancer Therapies
Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Time frame: Up to 15 years
Survival Status Assessment
Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.
Time frame: Up to 15 years
Percentage of Participants With Cause of Death
Time frame: Up to 15 years
Overall Rate of Replication-competent RCR/RCL
Time frame: Up to 15 years
Percentage of Participants With Vector Integration Site(s) for RCR/RCL or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
Time frame: Up to 15 years
Percentage of Participants With Status of Primary Malignant Disease
Time frame: Up to 15 years
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Children's Hospital of Orange County
Orange, California, United States
Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
...and 81 more locations