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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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Trial Profile

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: 14 May 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

  • 15 Apr 2025 Planned End Date changed from 14 Mar 2025 to 25 Mar 2026.
  • 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.

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