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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000113
• EU PAS number:
  EUPAS1000000113
• Study ID:
  1000000113
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  European Union
• Study description:
  The purpose of this PASS is to collect long-term, real-world safety and effectiveness data of patients treated with tabelecleucel, including paediatric and elderly patients. To date, the safety profile of tabelecleucel among paediatric patients remains consistent with that of the overall population; however, additional data are warranted to characterise further the tabelecleucel safety profile in paediatric patients with EBV+ PTLD following HCT or SOT. In addition, the average age of adult patients with PTLD has increased over the last decade due to improved standard, thus, further characterisation of the benefit- risk profile of tabelecleucel in elderly patients (≥ 65 years old) is needed.; All patients who are scheduled to receive tabelecleucel in the real-world setting will be eligible to participate in the study. ; Currently treated in any tabelecleucel clinical study or expanded access program will not be eligible to participate in the study.; The treatment decision is to be made prior to and independent of participation in this observational study, and the patient’s treatment plan will not be affected by the participation in this study.; Patients will receive tabelecleucel dosing based on the approved product information (Summary of Product Characteristics, SmPC) and all decisions regarding the treatment of enrolled patients will be made by the treating physician in accordance with the local best clinical practice.; Study objectives: ; Primary: ; To describe the safety of tabelecleucel in patients with EBV+ PTLD following HCT or SOT in a real-world setting. ; ; Secondary: ; 1. To describe the effectiveness of tabelecleucel in patients with EBV+ PTLD following HCT or SOT in a real-world setting. ; 2. To describe the patient population treated with tabelecleucel for EBV+ PTLD following HCT or SOT in a real-world setting. ; 3. To describe tabelecleucel treatment patterns, including dosing and schedule, in patients with EBV+ PTLD following HCT or SOT in a real-world setting
• Study status:
  Planned

Research institutions and networks

Institutions

ORACLE LIFE SCIENCES

Pierre Fabre Médicament

Study timelines

Date when funding contract was signed

Planned: 28/07/2023

Actual: 12/07/2023

Study start date

Planned: 31/12/2024

Date of final study report

Planned: 01/01/9999

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pierre Fabre Médicament

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)