Neurologic events MT103-211 (extension To evaluate central Primary analysis cohort only): An open nervous system (CNS) complete: 11 July label, multicentre, Phase symptoms and explore 2014 II study to evaluate potential predictive Extension cohort efficacy and safety of the factors for CNS events analysis report: 18 bi-specific T-cell engager associated with February 2015. (BiTE) antibody blinatumomab. blinatumomab in adult CSR available: June subjects with 2018. relapsed/refractory B precursor acute lymphoblastic leukaemia (ALL). Paediatric patients1 MT103-205: A To determine the CSR available Phase I/II, single arm, recommended Phase II third/fourth quarter dose finding/efficacy dose of blinatumomab. of 2015 (submitted in study in patients < 18 clinical dossier). To assess the efficacy of years with B precursor blinatumomab. 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. This study will provide a Study 00103311 To evaluate the effect of First quarter of 2017. more complete dataset (TOWER): A Phase III, blinatumomab on OS from which to evaluate OS randomised, open label when compared to seen with blinatumomab study to investigate the standard of care and help to better efficacy of BiTE antibody chemotherapy. differentiate between the blinatumomab versus adverse events associated standard of care with blinatumomab and chemotherapy in adult those associated with subjects with cytotoxic chemotherapy in relapsed/refractory a heavily pre-treated acute patient population with a lymphoblastic leukaemia rapidly progressing (ALL). disease. Paediatric patients 20120215: A To evaluate EFS in the July 2024. randomised, open label, blinatumomab arm controlled Phase III versus EFS in the adaptive to standard consolidation investigate the efficacy, chemotherapy arm. safety, and tolerability of the BiTE antibody blinatumomab as consolidation therapy versus conventional chemotherapy in paediatric patients with
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.
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