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Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Trial Profile

Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

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At a glance

  • Drugs Blinatumomab (Primary) ; Asparaginase; Asparaginase; Cyclophosphamide; Cytarabine; Cytarabine; Cytarabine; Dexamethasone; Dexamethasone; Etoposide; Folinic acid; Folinic acid; Hydrocortisone; Mercaptopurine; Methotrexate; Methotrexate; Methotrexate; Mitoxantrone; Pegaspargase; Tioguanine; Vincristine
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 24 Sep 2019 According to an Amgen media release, the company looks forward to discussing the data from this study with regulatory authorities. The interim data will be submitted to a future medical conference and for publication.
    • 24 Sep 2019 Interim Results published in the Amgen Media Release.
    • 24 Sep 2019 According to an Amgen media release, based on the recommendation of the COG DMC this study has closed to accrual for the high-risk and intermediate risk-arm. The DMC closure decision was based on a strong trend towards improved disease-free survival and improved overall survival, markedly lower toxicity, and better minimal residual disease (MRD) clearance for BLINCYTO compared to chemotherapy.
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