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

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: 09 Feb 2024

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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

    • 06 Feb 2024 According to an Amgen media release, The FDA granted Priority Review for the Company's supplemental BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) based in part on the Phase 3 E1910 study.Based on the Priority Review designation, the PDUFA date for BLINCYTO is June 21, 2024. Additional global regulatory authority submissions are underway.
    • 12 Dec 2023 Results of a sub-group analysis assessing outcomes of patients in the blinatumomab arm of the trial who received all 4 cycles of blinatumomab compared to those who received 1-2 cycles presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 06 Dec 2023 Planned End Date changed from 31 Dec 2023 to 4 Dec 2024.
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