drugset / Trial / NCT02326584
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-12
- Primary completion
- 2017-01-30
- Completion
- 2018-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vadastuximab talirine | Unknown | — | Intravenous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | — |
| Background | Cytarabine | Small molecule | 3000 mg/m2 | — |
| Background | Daunorubicin | Small molecule | 60 mg/m2 | — |