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

A Phase I, Open-label, Cohort Dose Escalation Trial With BI 836858 in Patients With Refractory or Relapsed Acute Myeloid Leukemia and Patients With Acute Myeloid Leukemia in Complete Remission With High Risk to Relapse.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	BI 836858	Monotherapy with BI 836858 administered as intravenous infusion

Timeline

• Start date: 2012-09-13
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2012-09-24
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

5 sites across 1 country: United States