Clinical trial NCT03628612: Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
Official title: Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
Multiple Myeloma
DLBCL
ALL, Adult and Pediatric
T Cell Lymphoma
Lead sponsor: Autolus Limited
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.

Detailed description: The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.

Eligibility criteria: Inclusion Criteria:

1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
2. Patients must have provided informed consent for long-term follow-up study prior to participation.
3. Patients must be able to comply with the study requirements.

Exclusion Criteria:

1. There are no specific exclusion criteria for this study.

Primary outcomes:
measure: Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
timeFrame: For up to 15 years
Secondary outcomes:
measure: Overall Survival following first AUTO CAR T cell therapy infusion.
timeFrame: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
measure: Duration of supportive care
timeFrame: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
measure: Duration of response
timeFrame: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
measure: Progression-free survival
timeFrame: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
measure: Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion
timeFrame: For up to 15 years
measure: Proportion of patients with detectable vector copy number (VCN) in peripheral blood
timeFrame: Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
measure: Testing for Insertional mutagenesis in case of a new malignancy
timeFrame: For up to 15 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Austin
country: United States
facility: St David's South Austin Medical Center
state: Texas
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
References: