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)

Trial Profile

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)

Recruiting
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
  • Most Recent Events

    • 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.
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