At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
BI 836858drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating BI 836858 for Leukemia, Myeloid, Acute. Completed, enrolled 30 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedSep 2012
Primary CompletionMay 2018
TodayJul 2026
First PostedSep 24, 2012
Enrollment StartSep 13, 2012
Primary CompletionMay 21, 2018
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 13.8 years ago
Interventions
BI 836858drug
Monotherapy with BI 836858 administered as intravenous infusion