Neuf Study 20160441
Research type
Research Study
Full title
Expanded Access of Blincyto® in Patients with Acute Lymphoblastic Leukaemia: A Retrospective Observational Study
IRAS ID
231574
Contact name
Sally Wetten
Contact email
Sponsor organisation
Amgen Ltd.
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
Blincyto® (blinatumomab) was approved by the FDA in December 2014 and it was conditionally approved in November 2015 by the EMA for the treatment for adults with relapsed and/or refractory (R/R) Philadelphia chromosome-negative (Ph-) B-precursor Acute Lymphblastic Leukaemia (ALL). Additionally, in August 2016 the FDA also approved the use of Blinctyo in paediatric patients. \n\nDue to the high level of unmet clinical need in these patients, Amgen has been providing Blincyto via an early access program for a number of ALL subgroups who met pre-specified disease criteria in countries where such programs were permitted.\n\nThis study aims to characterise the ALL population and the specific subgroups receiving Blincyto in the EA setting and describe selected outcomes and Blincyto utilisation.\n\nThis is a retrospective, observational, multi-centre study involving medical record review of patients who initiated Blincyto in an EA program.\n\nThe Primary Objective is to describe the clinical characteristics and treatment patterns of patients with B precursor ALL, having received Blincyto in the EA setting and identify clinically relevant subgroups.\n\nThe secondary Objectives are:\n- To describe the effectiveness of Blincyto.\n- To describe Blincyto utilization.\n\nThis study is planned to be conducted in 6 countries: France, Germany, Italy, Spain, UK and Russia. \n\nInclusion criteria:\n- B-precursor ALL patients who initiated Blincyto in an EA setting from 1st Jan2014 up until 31st Dec2016\n\nExclusion criteria:\n- Patients enrolled in Amgen EA protocol 20130320\n- Patients who do not provide informed consent\n- Patient’s medical chart is not available for data extraction\n\nThe pool of eligible patients in the 6 countries is estimated to be approximately 400-500 B-precursor ALL patients. However, the actual number of patients that will be included in the study will depend on the results of site feasibility, willingness of sites to participate in the study and availability of the medical records.
REC name
South West - Frenchay Research Ethics Committee
REC reference
17/SW/0264
Date of REC Opinion
16 Feb 2018
REC opinion
Further Information Favourable Opinion