Solid and Hematological Malignancies
Conditions
Interventions
Subjects who have received gene-modified cells will roll-over into this stud and will be followed up for up to 15 years from the time they received gene-modified cell therapy. Subjects will not receiv
Sponsors
Ikuta Mari
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent or discontinued the parent study and must have completed the minimum duration of follow up assessments in the parent study, as applicable 2. The subject must understand and voluntarily sign an Informed Consent Form and/or an Informed Assent Form prior to any study-related assessments/procedures being conducted 3. In the investigator's judgment, the subject is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion criteria
Exclusion criteria: Not Applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the occurrence of the following late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cells: -Neurologic disorders: type, date of onset, severity, treatment, and date of resolution -Autoimmune disorders: type, date of onset, severity, treatment, and date of resolution -Hematologic disorders: type, date of onset, severity, treatment, and date of resolution -Serious infections (ie, viral, bacterial, or fungal): type, organism, and timing of infection -Secondary malignancies: time to development of the secondary malignancy, type, location, and staging Mechanism of RCR/RCL and/or insertional mutagenesis | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subsequent anti-cancer therapies - Survival status - Cause of death - Evidence of immune reconstitution - Rates of RCR/RCL | — |
Countries
Ausria, Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, North America, Spain, Switzerland, UK
Contacts
Public ContactClinical Operations
Gilead Sciences, K.K.
Outcome results
None listed