An observational, Post-Authorisation Safety Study (PASS) to describe the safety and effectiveness of tabelecleucel in patients with Epstein-Barr Virus positive (EBV+) Post-Transplant Lymphoproliferative Disease (PTLD) in a real-world set
An observational, Post-Authorisation Safety Study (PASS) to describe the safety and effectiveness of tabelecleucel in patients with Epstein-Barr Virus positive (EBV+) Post-Transplant Lymphoproliferative Disease (PTLD) in a real-world set
An observational, Post-Authorisation Safety Study (PASS) to describe the safety and effectiveness of tabelecleucel in patients with Epstein-Barr Virus positive (EBV+) Post-Transplant Lymphoproliferative Disease (PTLD) in a real-world set
How is the study conducted?
This is an observational post-authorisation safety study (PASS) conducted in several European countries. A PASS is an observational study looks at how things work in everyday life. This type of study does not have strict conditions to be included like in clinical interventional trials, as the aim is to reflect the real life.
A PASS is a study conducted after a drug has been authorised for use by health authorities. The aim is mainly to obtain further information on the safety of a drug.
The study will be conducted in people for whom the physicians had decided to treat them with tabelecleucel in the real life. All patients will be treated and monitored according to the local clinical practice. No specific visit dates will be required for this study. The study will include a 3-year follow-up period from the first dose of treatment with tabelecleucel.
Who can take part in the trial ?
The study will take place in Europe.
The following people could participate in the study:
- People diagnosed with the disease “EBV+ PTLD” following transplant
- Having prescribed tabelecleucel
- Who will agree to participate in the study and having data collected
What are the objectives of the trial and how are they evaluated ?
The main objective of the study is to describe the safety of tabelecleucel collected in the everyday life.
The secondary objectives are:
- To describe how well tabelecleucel works
- To learn more about the types of people treated with tabelecleucel
- To gather information on how tabelecleucel is being given.
What is the study Medication ?
People will receive tabelecleucel prescribed by their physician. The dose received will be the one according to the usual routine practice.
More information
This study will be conducted according to ethical considerations and will follow the rules for conducting such study. The study will not start before it will be approved. People will have to provide their consent to participate.