A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
Phase of Trial: Phase III
Latest Information Update: 03 Apr 2018
At a glance
- Drugs Blinatumomab (Primary) ; Crisantaspase; Daunorubicin; Dexamethasone; Ifosfamide; Methotrexate; Pegaspargase; Vincristine
- Indications Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Registrational; Therapeutic Use
- Sponsors Amgen
- 03 Apr 2018 Planned number of patients changed from 320 to 202.
- 27 Mar 2017 Planned End Date changed from 1 Dec 2021 to 1 Dec 2022.
- 27 Mar 2017 Planned primary completion date changed from 1 Jan 2019 to 30 Jan 2020.