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A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

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A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Feb 2025

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At a glance

  • Drugs Blinatumomab (Primary) ; Cyclophosphamide; Cyclophosphamide; Cytarabine; Cytarabine; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Mercaptopurine; Methotrexate; Methotrexate; Methotrexate; Pegaspargase; Pegaspargase; Prednisone; Rituximab; Vincristine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 29 Jan 2025 According to an Amgen media release, company announced that the European Commission (EC) has approved BLINCYTO (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) on basis of this trial.
    • 05 Dec 2024 Planned End Date changed from 4 Dec 2024 to 14 Mar 2025.
    • 06 Aug 2024 According to an Amgen media release, data from this study published in the New England Journal of Medicine.

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