Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Conditions

Solid and Hematological Malignancies

Brief summary

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 (eg, viral, bacterial, or fungal): type, organism, and timing of infection, New malignancies: time to development of the New malignancy, type, location, staging and molecular mechanism (including testing for presence of the chimeric antigen receptor transgene and RCR/RCL, Height, weight, and sexual maturation of pediatric and adolescent subjects

Detailed description

Subsequent anti-cancer therapies, Survival status, Cause of death, Overall rates of RCR/RCL, Status of the primary malignant disease

Related papers

No related papers found yet.

Interventions

DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion

DRUGTecartus 0.4 - 2 x 10e8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

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 (eg, viral, bacterial, or fungal): type, organism, and timing of infection, New malignancies: time to development of the New malignancy, type, location, staging and molecular mechanism (including testing for presence of the chimeric antigen receptor transgene and RCR/RCL, Height, weight, and sexual maturation of pediatric and adolescent subjects	—

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 (eg, viral, bacterial, or fungal): type, organism, and timing of infection, New malignancies: time to development of the New malignancy, type, location, staging and molecular mechanism (including testing for presence of the chimeric antigen receptor transgene and RCR/RCL, Height, weight, and sexual maturation of pediatric and adolescent subjects

—

Secondary

Measure	Time frame
Subsequent anti-cancer therapies, Survival status, Cause of death, Overall rates of RCR/RCL, Status of the primary malignant disease	—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed