NCT02614560 (Clinical Trial/ Vadastuximab Talirine)

Study Title

A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients (NCT02614560)

Trial Description

This study will examine the safety and anti-leukemic profile of SGN-CD33A (vadastuximab talirine) in patients with relapsed chemo-resistant AML, who are given vadastuximab talirine in combination with standard treatments before a planned stem cell transplant, or vadastuximab talirine alone after a stem cell transplant.

The main purpose of the study is to find the best dose and determine the anti-leukemic activity of vadastuximab talirine, given either pre- or post-allogeneic stem cell transplant (alloSCT) for adults with relapsed or refractory AML. This will be determined by assessing the safety and tolerability of vadastuximab talirine. In addition, the pharmacokinetic profile and anti-leukemic activity of the study treatment will be assessed

This trial is sponsored by Seattle Genetics, Inc.

Study Data

  • Condition: Acute Myeloid Leukemia
  • Interventions:
    • Drugs used in this trial
      • Fludarabine
      • Melphalan
      • Methotrexate
      • Tacrolimus
      • vadastuximab talirine
  • Phase: I & II
  • Estimated Enrollment: 102
  • Start: November 2015
  • Estimated Completion: March 2023
  • Last verified: January 2016
  • Last updated: January 2016

Study Schematic

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Last Editorial review: January 22, 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.