Neurologic events MT103-211 (extension cohort only): An open label, multicentre, Phase II study to evaluate efficacy and safety of the bi-specific T-cell engager (BiTE) antibody blinatumomab in adult subjects with relapsed/refractory B precursor acute lymphoblastic leukaemia (ALL). To evaluate central nervous system (CNS) symptoms and explore potential predictive factors for CNS events associated with blinatumomab. Primary analysis complete: 11 July 2014 Extension cohort analysis report: 18 February 2015. CSR available: June 2018. Paediatric patients1 MT103-205: A Phase I/II, single arm, dose finding/efficacy study in patients < 18 years with B precursor ALL in second or later bone marrow relapse, in any marrow relapse after allogeneic haematopoietic stem cell transplantation (HSCT), or refractory to other treatments; > 25% blasts in bone marrow. To determine the recommended Phase II dose of blinatumomab. To assess the efficacy of blinatumomab. CSR available third/fourth quarter of 2015 (submitted in clinical dossier). This study will provide a more complete dataset from which to evaluate OS seen with blinatumomab and help to better differentiate between the adverse events associated with blinatumomab and those associated with cytotoxic chemotherapy in a heavily pre-treated patient population with a rapidly progressing disease. Study 00103311 (TOWER): A Phase III, randomised, open label study to investigate the efficacy of BiTE antibody blinatumomab versus standard of care chemotherapy in adult subjects with relapsed/refractory acute lymphoblastic leukaemia (ALL). To evaluate the effect of blinatumomab on OS when compared to standard of care chemotherapy. First quarter of 2017. Paediatric patients 20120215: A randomised, open label, controlled Phase III adaptive to investigate the efficacy, safety, and tolerability of the BiTE antibody blinatumomab as consolidation therapy versus conventional chemotherapy in paediatric patients with To evaluate EFS in the blinatumomab arm versus EFS in the standard consolidation chemotherapy arm. July 2024.
high risk first relapse of B-precursor ALL. Planned Studies Selected identified risks, potential risks, and missing information as well as other serious adverse events Study 20150136: An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices Primary Objectives: 1) To characterise the safety profile of blinatumomab in routine clinical practice in countries in the EU. 2) To estimate the frequency and types of medication errors identified in patient charts. Secondary objectives: 1) To estimate the incidence of other serious adverse events, that is, serious adverse events not included in the primary objective. 2) To characterise safety and effectiveness endpoints among patient subgroups defined by demographic and clinical factors. 3) To characterise the effectiveness of blinatumomab in routine clinical practice. 4) To describe blinatumomab utilisation and healthcare resource use in routine clinical practice. Fourth quarter 2021 Neurologic events, medication errors. 20150163: Survey of physicians, pharmacists and nurses involved in the prescribing, preparation and administration of blinatumomab in Europe to evaluate the effectiveness of additional risk minimisation measures. To evaluate the distribution, knowledge and impact on behaviour of additional risk minimisation measures for physicians, pharmacists and nurses. Second quarter 2019 Study 20150228: A cross sectional survey of patients and caregivers receiving blinatumomab in routine clinical practice in Europe to evaluate the effectiveness of additional risk minimisation Primary objective: To assess knowledge about and receipt of the educational materials. Secondary objectives: 1) To determine the level of understanding of the information in the educational Third quarter 2018