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

NCT01690624

Phase 1 Completed 30 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
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