Long-term follow-up after GM T cell treatment (GC-LTFU-001)
Research type
Research Study
Full title
Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells
IRAS ID
237857
Contact name
Claire Roddie
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2017-001465-24
Duration of Study in the UK
16 years, 5 months, 30 days
Research summary
Current European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines recommend clinical monitoring and follow-up after treatment with gene therapy medicinal products that uses a carrier retroviral vector. Gene therapy involves the introduction of normal genes into cells in place of missing or defective ones in order to correct genetic disorders. Retroviral vectors are used for the transfer of these genes. Such a vector was used in the previous treatment study to put new genes into the patients’ T cells to help them identify and kill specific cancer cells. As such, all patients who have participated in a Celgene supported gene-modified (GM) T cell research study, and have received treatment with GM T cells, will be asked to participate in this long-term follow-up (LTFU) study to be monitored for delayed side effects.
The study population consists of any paediatric or adult patients who received at least one GM T cell infusion as part of a previous Celgene-sponsored or Celgene alliance partner sponsored studies. There are no paediatric parent studies currently planned for the UK therefore there will be no paediatric patients recruited in the UK for this LTFU study.
Patients enrolled in this LTFU protocol will have safety tests, central and local laboratory tests and may complete patient quality of life questionnaires at scheduled intervals. The timing for all assessments in this LTFU protocol is based upon the date the patient last received GM T cells in the parent study. Patients will be followed for up to 15 years starting from the date they are last given GM T cells, until study withdrawal, or death, whichever occurs first.
The number of patients participating in this LTFU study will be determined by the number of patients (adults and paediatric) participating in GM T cells Celgene supported studies globally.REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0056
Date of REC Opinion
24 Feb 2019
REC opinion
Further Information Favourable Opinion