Solid and Hematological Malignancies
Conditions
Brief summary
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, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.
Interventions
BIOLOGICALAxicabtagene Ciloleucel
No investigational product will be administered
BIOLOGICALBrexucabtagene Autoleucel
No investigational product will be administered
BIOLOGICALAnitocabtagene autleucel
No investigational product will be administered
BIOLOGICALKITE-753
No investigational product will be administered
BIOLOGICALKITE-197
No investigational product will be administered
BIOLOGICALKITE-363
No investigational product will be administered
Sponsors
Kite, A Gilead Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable * The individual must understand and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
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) | Up to 15 years | Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies. |
| Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) | Up to 15 years | Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies. |
| Height of Pediatric and Adolescent Participants | Up to 15 years | — |
| Weight of Pediatric and Adolescent Participants | Up to 15 years | — |
| Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score | Up to 15 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Subsequent Anticancer Therapies | Up to 15 years | Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs. |
| Survival Status Assessment | Up to 15 years | 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. |
| Percentage of Participants With Cause of Death | Up to 15 years | — |
| Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) | Up to 15 years | — |
| Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product | Up to 15 years | — |
| Percentage of Participants With Status of Primary Malignant Disease | Up to 15 years | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
STUDY_DIRECTORKite Study Director
Kite, A Gilead Company
Outcome results
None listed