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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)

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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)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs Blinatumomab (Primary) ; Crisantaspase; Crisantaspase; Cyclophosphamide; Daunorubicin; Dexamethasone; Ifosfamide; Methotrexate; Pegaspargase; Pegaspargase; Vincristine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

Most Recent Events

  • 10 Dec 2024 Preliminary results (n=56), presented at the 66th American Society of Hematology Annual Meeting and Exposition
  • 31 Aug 2024 This trial has been completed in Portugal (End date: 2022-12-05) according to European Clinical Trials Database record.
  • 09 Feb 2023 This trial has been completed in Poland, according to European Clinical Trials (5 Dec 2022)Database record.

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