Study Title
Phase I/II – Brentuximab/5-Azacytidine in Acute Myeloid Leukemia (AML) (NCT02096042)
Trial Description
This clinical research study is made up of 3 phases: a Pilot Phase, Phase I, and Phase II trial.
The goal of the Pilot Phase is to learn how safe it is to give the study drug brentuximab vedotin (also known as SGN-035) to patients with Acute Myeloid Leukemia or AML. The goal of Phase I is to learn more about the safety of the combination of brentuximab vedotin with azacytidine. The goal of Phase II is to learn if the combination of brentuximab vedotin and azacytidine can help to control AML.
This trial is sponsored by Seattle Genetics/ M. D. Anderson Cancer. [1]
Study data
- Condition: Leukemia
- Interventions:
- Drugs used in this trial
- brentuximab vedotin (Adcetris®; Seattle Genetics, Inc.)
- 5-Azacytidine (Vidaza®; Celgene Co.)
- Drugs used in this trial
- Phase: I & II
- Estimated Enrollment: 61
- Start: April 2014
- Estimated Primary Completion: April 2019 (Final data collection date for primary outcome measure
- Last verified: May 2015
Study Schematic
Last Editorial review: July 11, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
