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A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL).

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Trial Profile

A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab (MT103) in Pediatric and Adolescent Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL).

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 28 Feb 2023

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At a glance

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

    • Most Recent Events

    • 24 Feb 2023 Results of pooled analysis (n=683) assessing the association between bBMB% and treatment outcomes in relapsed/refractory (R/R) B-acute lymphoblastic leukemia from 5 trials (NCT01209286, NCT01466179, NCT01471782, NCT02013167, NCT02187354), published in the Cancer.
    • 02 Nov 2019 Results published in the Clinical Pharmacokinetics
    • 29 Aug 2018 The European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) as monotherapy for the treatment of pediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL), which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation, according to an Amgen media release.
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