drugset / Trial / NCT02614560
A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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 sequence with standard treatments before a planned stem cell transplant, or as maintenance therapy 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.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-02-10
- Completion
- 2017-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vadastuximab talirine | Unknown | — | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |