Kantonsspital St.Gallen
login

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
charts
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.
Hypothesis/Estimation
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