A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)

Trial Profile

A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia (Alcantara Study)

Completed
Phase of Trial: Phase II

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Blinatumomab (Primary)
  • Indications Acute lymphoblastic leukaemia
  • Focus Therapeutic Use
  • Acronyms Alcantara
  • Sponsors Amgen
  • Most Recent Events

    • 12 Aug 2017 Results of association of haematopoietic stem cell involvement and resistance to blinatumomab therapy data from four studies including this study published in the Blood
    • 11 Jul 2017 According to an Amgen media release, the US FDA has approved the sBLA for BLINCYTO (blinatumomab) to include overall survival data from the Phase 3 TOWER study. The approval converts BLINCYTO's accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
    • 11 Jul 2017 According to an Amgen media release, the approval expands the indication of BLINCYTO for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
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