Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AUTO CAR T cell therapy.
- Who it may be relevant to
- Registry 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. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
Overview
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.
Interventions
- Biological AUTO CAR T cell therapy
No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
Primary outcome measures
- Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy [Time frame: For up to 15 years]
Secondary outcome measures (7)
- Overall Survival following first AUTO CAR T cell therapy infusion. [Time frame: 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]
- Duration of supportive care [Time frame: 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]
- Duration of response [Time frame: 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]
- Progression-free survival [Time frame: 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]
- Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion [Time frame: For up to 15 years]
- Proportion of patients with detectable vector copy number (VCN) in peripheral blood [Time frame: 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]
- Testing for Insertional mutagenesis in case of a new malignancy [Time frame: For up to 15 years]
Eligibility criteria
Inclusion criteria
- Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- Patients must have provided informed consent for long-term follow-up study prior to participation.
- Patients must be able to comply with the study requirements.
Exclusion criteria
- There are no specific exclusion criteria for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United Kingdom · 5 centers
- Queen Elizabeth University Hospital — Glasgow
- University College London Hospitals NHS Foundation Trust — London
- Manchester Royal Infirmary Hospital — Manchester
- Royal Manchester Children's Hospital — Manchester
- Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne
United States · 3 centers
- University of Miami — Miami
- Washington University in St. Louis — St Louis
- St David's South Austin Medical Center — Austin
Identifiers
NCT: NCT03628612 · AUTO-LT1