Study Title
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML (NCT02326584)
Trial Description
This study will examine the safety profile of vadastuximab talirine (SGN-CD33A) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment.
This 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-leukemic activity of the study treatment will be assessed.
This trial is sponsored by Seattle Genetics, Inc.
Study Data
- Condition:
- Acute Myeloid Leukemia
- Acute Myelogenous Leukemia
- Interventions:
- Drugs used in this trial
- Standard dose cytarabine for induction
- SGN-CD33A
- Daunorubicin
- High dose cytarabine for consolidation
- Drugs used in this trial
- Phase: I
- Estimated Enrollment: 144
- Start: December 2014
- 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.
