Long-term follow-up of people treated with gene-modified T cell therapy
Follows people who received gene-modified T cell therapy in an earlier study for cancer.
Plain-language title generated from the registry record
Registry title: Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Key facts
- Where
- Bergamo, Bologna, Genoa, Milan, Monza, Naples, Rome, Rozzano, Turin, and Udine, ItalySee the 12 sites
- Phase
- Phase 2/3
Where in Italy
- Azienda Ospedaliera Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Humanitas Research HospitalRozzano, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene
- Trial code
- NCT03435796EU 2023-504201-36-00
- Record updated
- 2 November 2026
- Original description
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.Read full original descriptionShow less
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Inclusion: Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable; Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion: Not Applicable; Other protocol-defined inclusion/exclusion criteria apply.