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
Interventions
Trade Name: Yescarta
Product Name: axicabtagene ciloleucel
Product Code: [axicabtagene ciloleucel]
Pharmaceutical Form: Dispersion for infusion
INN or Proposed INN: axicabtagene ciloleucel
Current Spo
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The subject must have received an infusion of gene-modified cells in a completed Kite sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable 2) The subject must understand and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 studyrelated 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? no Number of subjects for this age range: 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 genemodified 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