At a glance
ClinicalIndex Comparison Record- ✓Relapsed or refractory AML (Phase I Dose Escalation only)
- ✓Untreated AML, age ≥65, ineligible for standard intensive therapy
- ✓Histologically or cytologically confirmed AML per WHO classification
- ✓Eligible for treatment with decitabine
- ✕Acute promyelocytic leukemia (APL, FAB M3)
- ✕Candidate for allogeneic stem cell transplantation
- ✕Active chronic graft versus host disease requiring immunosuppressive treatment
- ✕Prior hypomethylating agent (Phase I Extension and Phase II only)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Phase I/II Trial to Determine the Maximum Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 836858 in Combination With Decitabine in Patients With Acute Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating Decitabine and BI 836858 for Leukemia, Myeloid, Acute. Completed, enrolled 49 participants across 14 sites in 4 countries.
Detailed Summary
Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.