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An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

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Trial Profile

An Open-label, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2022

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At a glance

  • Drugs Blinatumomab (Primary) ; Dexamethasone
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 04 May 2022 According to a BeiGene media release, the company announced that the China National Medical Products Administration (NMPA) has granted conditional approval of BLINCYTO for injection for the treatment of pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia. The NMPA granted conditional approval for adult patients in this indication in December 2020. The approval is based on ex-China data and interim analysis results of this study.
    • 16 Apr 2021 Status changed from active, no longer recruiting to completed.
    • 07 Dec 2020 According to a BeiGene media release, China National Medical Products Administration (NMPA) has approved BLINCYTO (blinatumomab) for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).The approval of BLINCYTO was based on results from this trial.

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