drugset / Trial / NCT01690624
BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients With AML in Complete Remission With High Risk to Relapse
Non-randomizedSequentialOpen-labelTreatment
Summary
Patients with acute myeloid leukemia who experience a relapse after at least one prior regimen may be enrolled in this trial. In addition, acute myeloid leukemia patients who are in complete remission with high risk to relapse may be eligible for this trial. The trial will examine whether monotherapy with BI 836858 is safe and tolerable at escalating dose levels.
Timeline
- Start
- 2012-09-13
- Primary completion
- 2018-05-21
- Completion
- 2018-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 836858 | Protein / enzyme biologic | 10 mg | Intravenous |
| Subject | BI 836858 | Protein / enzyme biologic | 20 mg | Intravenous |
| Subject | BI 836858 | Protein / enzyme biologic | 40 mg | Intravenous |