Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
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.
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.
Hematologic,
Leukemia,
Lymphoma,
Pediatric Leukemia,
Pediatric Lymphoma
N/A
Both
Not Available
Not Available
Kassim, Adetola
International
Vanderbilt University
07-08-2022
Eligibility
Not Available
ALL
false
Inclusion Criteria:
The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable
The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria:
Exclusion Criteria: none
The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable
The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria:
Exclusion Criteria: none
