B-cell malignancies and Acute Myeloid Leukemia MedDRA version: 21.1 Level: PT Classification code 10026801 Term: Mantle cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10008977 Term: Chronic lymphocytic leukemia recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification c
Conditions
Sponsors
Kite Pharma, Inc.
Eligibility
Sex/Gender
All
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The subject must have received an infusion of gene-modified cells in a completed Kite sponsored parent study, has not withdrawn full consent or discontinued the parent study, and must have completed the minimum duration of follow-up assessments in the parent study, as applicable 2) The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 (ICF) or an Informed Assent Form prior to any study-related assessments or 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 Are the trial subjects under 18? yes Number of subjects for this age range: 27 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 427 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190
Exclusion criteria
Exclusion criteria: There are no specific exclusion criteria for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious adverse events (SAEs) suspected to be possibly related to gene-modified cells, including neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies Evaluate mechanism of replication-competent retrovirus/replication competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects treated with gene modified cells ;Secondary Objective: - Determine the time to next treatment after administration of gene-modified cell therapy in the completed parent study - Determine survival status - Determine cause of death - Evaluate immune reconstitution - Evaluate the incidence of RCR/RCL ;Primary end point(s): Assess the occurrence of the following late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cells: Neurologic disorders Autoimmune disorders Hematologic disorders Serious infections Secondary malignancies Mechanism of RCR/RCL and/or insertional mutagenesis Height, weight, and sexual maturation of pediatric and adolescent subjects ;Timepoint(s) of evaluation of this end point: Approximately every 3 months from Month 6 to Month 18 after initial infusion in parent study, Month 24, and then annually. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Subsequent anticancer therapies - Survival status - Cause of death - Evidence of immune reconstitution - Rates of RCR/RCL ;Timepoint(s) of evaluation of this end point: Approximately every 3 months from Month 6 to Month 18 after initial infusion in parent study, Month 24, and then annually. | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Kite Pharma, Inc.
Outcome results
None listed