An observational, Post Authorisation Safety Study to describe the safety and effectiveness of tabelecleucel in patients with Epstein-Barr Virus positive Post-Transplant Lymphoproliferative Disease

Tabelecleucel is a treatment designed to target and destroy cells infected with Epstein-Barr Virus (EBV), which is a common virus that can cause serious health problems. 
Since 2022, this treatment has been authorized in Europe for use in both adults and children (2 years and older) who have Epstein-Barr Virus positive (EBV+) Post-Transplant Lymphoproliferative Disease (PTLD). This disease can occur after someone has received an organ (solid organ transplantation, SOT) or cell transplant (hematopoietic cell transplantation, HCT), hence the name PTLD. Due to the hampered immune system after a transplant the virus may not be controlled and proliferate unrestricted, which in some patients can lead to this special type of lymphoma.
Tabelecleucel is given to patients who have already tried at least one other treatment without success. For patients who had a SOT or HCT, the previous treatment is usually chemotherapy, with or without rituximab. 
Even though tabelecleucel has been approved, based on strong evidence from clinical studies showing a significant advancement for these patients with this condition, researchers need more information to fully understand how safe tabelecleucel is, especially in certain categories of patients.
This study aims to collect long-term, real-world safety and effectiveness data of patients treated with tabelecleucel, including pediatric and elderly patients, in compliance with European Health Authority guidelines for advanced therapy medicinal products.