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A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence With Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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Trial Profile

A Phase 1/2 Study of Vadastuximab Talirine Administered in Sequence With Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 28 Oct 2020

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At a glance

  • Drugs Vadastuximab talirine (Primary) ; Fludarabine; Melphalan; Methotrexate; Tacrolimus
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Seagen

    • Most Recent Events

    • 06 Mar 2017 According to a Seattle Genetics media release, the US FDA has lifted clinical hold on this trial. However, the company will not resume this trial given the challenges of developing therapies in this specific setting.
    • 06 Mar 2017 According to a Seattle Genetics media release, status changed from suspended to discontinued.
    • 27 Dec 2016 According to a Seattle Genetics media release, the US FDA has placed a partial clinical hold on several early stage trials of vadastuxumab talirine in acute myeloid leukemia, including this trial, due to potential risk of hepatotoxicity.
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