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
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
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 setting in Europe: EBVOLVE study
How is the study conducted?
This is an observational, post-authorization safety study conducted in several sites of the European countries where tabelecleucel has been already marketed. Any patient (≥ 2 years of age) with EBV+ PTLD who initiates treatment with tabelecleucel based on the approved product information will be invited to participate. Study participation is voluntary. Enrollment may occur at any time. Once a treatment decision has been made by the physician, patients enrolled in the study will be treated and monitored according to local clinical practice. Data on treatment with tabelecleucel will be collected in real-life. No additional visits, medical procedures, tests or examinations, medications, or treatments outside of usual medical care are required during the 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 ?
Patients (≥ 2 years of age) who agree with the collection and use of data and who are already set to receive tabelecleucel for EBV+ PTLD as part of their regular care can join this study.
Consent/non-opposition for the collection of data must be provided by the patients themselves, or by the parents or legal guardians in the case of minors.
Conversely, patients already involved and treated in any tabelecleucel clinical study or expanded access program will not be eligible to participate in the EBVOLVE study.
What are the objectives of the trial and how are they evaluated ?
The primary goal is to understand how safe tabelecleucel is for patients with the condition called EBV+ PTLD in a real-world setting.
The secondary goals are:
• To find out how well tabelecleucel works for these patients
• To learn more about the types of patients who are being treated with tabelecleucel for EBV+ PTLD
• To gather information on how tabelecleucel is being given to these patients, including how much and how often it is administered.