NCT01902329 (Clinical Trial/ Vadastuximab Talirine)

Study Title

A Safety Study of SGN-CD33A in AML Patients (NCT01902329)

Trial Description

This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML).

The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.

This trial is sponsored by Seattle Genetics, Inc.

Study Data

  • Condition:
    • Acute Myelogenous Leukemia
    • Acute Myeloid Leukemia
    • Acute Promyelocytic Leukemia
  • Interventions:
    • Drugs used in this trial
      • HMA
      • SGN-CD33A
  • Phase: I
  • Estimated Enrollment: 225
  • Start: July 2013
  • Estimated Completion: December 2017
  • Last verified: January 2016
  • Last updated: January 2016

Study Schematic

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Last Editorial review: February 22, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.