Kantonsspital St.Gallen

An Observatinal Study of Blinatumomab Safety and Effec-tiveness, Utillisation, and Treatment Practice

Tobias Silzle

abstract Study Background and Rationale
As a new treatment for acute lymphoblastic leukaemia (ALL), it is important tounderstand the safety and effective-ness of Blincyto (blinatumomab) as it isadministered in routine clinical practice. This study, developed to address
recommendations in the Committee for Medicinal Products for Human Use (CHMP) andPharmacovigilance Risk As-sessment Committee (PRAC) review, will be conducted in
selected countries in Europe. The proposed post-market observational study will providedescriptive data from the real-life use of Blincyto in patients in Europe.
Primary Objectives
• To characterize the safety profile of Blincyto in rou-tine clinical practice in
countries in Europe by characterising specified AEs
• To estimate the frequency and types of medication errors identified in patient
Secondary Objectives
• To estimate the incidence of all AEs
• To estimate the incidence of the specified AEs and all AEs
among patient subgroups defined by demographic and clinical factors
• To evaluate effectiveness endpoints (listed in overall and
among patient subgroups defined by demographic and clinical factors
• To describe Blincyto utilisation and select healthcare resource use in routine
clinical practice.
There is no formal hypothesis to be tested. The aim of this study is to characterise safety and effectiveness of Blina-tumumab in clinical Practice. Documentation of patients treated with Blinatumumab within this study is a prerequisite for reimbursement in Switzerland.
project homepage http://Not applicable
type of project clinical studies
status ongoing - recruiting phase
start of project 2018
end of project 2022
additional information Gemäss Limitatio der Spezialitätenliste wird Blinatumumab nur vergütet, wenn die erforderlichen Daten im Rahmen dieser Be-obachtungsstudie erfasst werden.
study design Observational Study
responsible person Dr.Tobias Silzle