drugset / Trial / NCT02096042
Phase I/II - Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This clinical research study is made up of 3 phases: a Pilot Phase, Phase 1, and Phase 2. The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin to patients with AML. The goal of Phase 1 is to learn more about the safety of the combination of brentuximab vedotin with azacytidine. The goal of Phase 2 is to learn if the combination of brentuximab vedotin and azacytidine can help to control AML.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | Intravenous |