Observational Study to Evaluate Secondary Malignancies of T-Cell Origin After Tisagenlecleucel Treatment

What this Trial Is About

This research focuses on patients who developed secondary malignancies of T-cell origin after receiving tisagenlecleucel treatment. It aims to understand if tisagenlecleucel plays a role in the development of these secondary cancers. The study includes individuals treated either in clinical trials or in commercial settings who have confirmed secondary T-cell malignancies. Participants are grouped into two cohorts one from clinical trial settings who discontinued prior studies or long-term follow-up, and another from post-marketing or commercial use, including those treated under special access programs. No new treatments are given, as this is an observational study collecting existing tissue and blood samples for analysis over approximately 15 years. During the study, researchers will analyze available tumor tissue and blood DNA samples to test for specific markers related to tisagenlecleucel. They will measure factors such as vector copy number and test for replication-competent lentivirus. Consent is required, and samples come from routine care. The study will track these measures at screening and continue to enroll eligible participants over many years.

A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy