Data collection during expanded access for tabelecleucel.
Research type
Research Study
Full title
An observational study to describe the patient population, tabelecleucel usage, treatment outcomes, and safety in patients with EBV driven diseases treated with tabelecleucel under the Expanded Access Program in Europe
IRAS ID
291217
Contact name
Sridhar Chaganti
Contact email
Sponsor organisation
Atara Biotherapeutics Switzerland GmbH
Duration of Study in the UK
3 years, 8 months, 30 days
Research summary
Lay Summary: An observational study to describe the patient population, tabelecleucel usage, treatment outcomes, and safety in patients with EBV-associated diseases treated with tabelecleucel under the Expanded Access Program in Europe
This study aims to describe the patient population, tabelecleucel usage, treatment outcomes, and safety in patients with EBV driven diseases treated with tabelecleucel under the Expanded Access Program (EAP) in Europe. Expanded access is a pathway that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials. The aim of expanded access is treatment provision and not research. This study will analyze data collected as part of providing access to tabelecleucel in the EAP in Europe. Data collected will therefore be very limited. This study will in no way interfere with treatment nor with ongoing clinical development of tabelecleucel.
The following characterizes this study:
• The decision to obtain treatment under expanded access is independent of and precedes the decision to enter this study.
• This study will analyze data that is collected as part of establishing eligibility for, and providing expanded access to, tabelecleucel in Europe.
• Data collection will place no additional burden to patients, except from annual survival follow up until two years after the date of first treatment.
• This study does not impede clinical development of tabelecleucel, as patients that enroll in an expanded access program are not eligible for clinical trials.REC name
London - Riverside Research Ethics Committee
REC reference
21/PR/0113
Date of REC Opinion
7 Apr 2021
REC opinion
Further Information Favourable Opinion