drugset / Trial / NCT02785900
Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.
Timeline
- Start
- 2016-05
- Primary completion
- 2017-10-03
- Completion
- 2017-10-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vadastuximab talirine | Unknown | 10 ug/kg | Intravenous |
| Background | 20 mg/m2 given IV x 5 days, every 4 weeks | Unknown | 20 mg/m2 | Intravenous |
| Background | 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks | Unknown | 75 mg/m2 | Subcutaneous |