Blincyto - Patient Survey
Research type
Research Study
Full title
A Cross-sectional Survey of Patients and Caregivers\nReceiving Blincyto in Routine Clinical Practice in\nEurope to Evaluate the Effectiveness of Additional\nRisk Minimisation Measures
IRAS ID
225156
Contact name
Naufil Alam
Contact email
Sponsor organisation
Amgen
Clinicaltrials.gov Identifier
EUPAS17829, EnCePP Register
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
This is cross-sectional survey of patients and caregivers receiving Blincyto in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimization measures. Blincyto® (blinatumomab) is indicated for the treatment of adults with Philadelphia chromosome–negative (Ph-) relapsed or refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) as a continuous infusion. Due to the seriousness and rarity of the indication, and the lack of alternative medicinal products for the subset of patients with Ph- disease, Blincyto was designated by the European Medicines Agency (EMA) as an orphan medicinal product. The product was approved in November 2015 by the European Commission. The purpose of the study is to describe the receipt of educational materials and the knowledge about the key safety messages in the educational materials among adult patients with Ph-R/R B-precursors ALL receiving Blincyto and their caregivers. \nThe study will be conducted in five (5) countries: France, Germany, Italy, Spain and the UK; in Hematology centres where Blincyto is prescribed or expected to be prescribed after its launch. Participating haemato-oncologists doctors and nurses will include patients and caregivers who fulfil all selection criteria in a consecutive manner according to the date of initiation of treatment with Blincyto until reaching the target number of patients and caregivers to be recruited per centre. Patients and caregivers who agree to participate in the study with written informed consent will be asked to complete a paper questionnaire after first discharge from hospital when they return to the clinic for a bag change or monitoring. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0020
Date of REC Opinion
4 Apr 2018
REC opinion
Further Information Favourable Opinion