drugset
drugset / Trial / NCT03207191

Trial to Find and Investigate a Safe Dose of F16IL2 and BI 836858 in Patients With AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

NCT03207191 ↗

Phase 1 Completed 15 enrolled Philogen S.p.A. Boehringer Ingelheim · collab
NaSingle-groupOpen-labelTreatment

Summary

Phase I, open label, single arm, non-randomized, multicenter, prospective dose escalation study in subjects with acute myeloid leukemia relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT).

Timeline

Start
2016-12-02
Primary completion
2020-03-26
Completion
2020-03-26

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
Subject BI 836858 Protein / enzyme biologic 80 mg Intravenous
Subject BI 836858 Protein / enzyme biologic 160 mg Intravenous
Subject F16IL2 Protein / enzyme biologic 1e+07 iu Intravenous
Subject F16IL2 Protein / enzyme biologic 2e+07 iu Intravenous
Subject F16IL2 Protein / enzyme biologic 3e+07 iu Intravenous

Indications

acute myeloid leukemia