Blinatumomab (MT103) in patients aged <18 years with B-Precursor ALL
Research type
Research Study
Full title
A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
IRAS ID
88215
Contact name
Ajay Vora
Contact email
Sponsor organisation
Amgen Research (Munich) GmbH
Eudract number
2010-024264-18
Research summary
Relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) is an aggressive malignancy. Patients in second or later bone marrow relapse or any marrow relapse after allogeneic hematopoietic stem cell transplantation (HSCT) need additional therapeutic approaches with new mechanisms of action.
BiTE® antibody blinatumomab (MT103) links together CD19 expressing B cells (a subset of leukemic cells) and T cells (’killer’ immune system cells). This activates the T cells which target the CD19+ B cells for destruction.
This clinical study is the first to be undertaken in paediatric and adolescent patients with ALL using blinatumomab. The overall aim is to assess whether blinatumomab has the potential to be a new curative therapy for this patient population.
The first part of the study, Phase I, was designed to ascertain the Maximum Tolerable Dose (MTD) of blinatumomab and determine a ’recommended dose’. Patients in the UK will participate in the second part, Phase II, of the study. The aim of this phase of the study is to assess the efficacy, safety, and tolerability of the ’recommended dose’ of blinatumomab in paediatric and adolescent patients with ALL.
About 40 children and adolescents will be taking part in Phase II of this study at centres in Europe, the US, and Canada. To take part in this second phase of the study patients must be less than 18 years of age at the time of enrolment and have relapsed or refractory ALL.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0255
Date of REC Opinion
24 Oct 2013
REC opinion
Further Information Favourable Opinion