drugset
drugset / Trial / NCT01838395

Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients

NCT01838395 ↗

Phase 2 Completed 42 enrolled BioLineRx, Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.

Timeline

Start
2013-04
Primary completion
2016-03
Completion
2023-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Motixafortide Peptide 0.5 mg/kg Subcutaneous
Subject Motixafortide Peptide 0.75 mg/kg Subcutaneous
Subject Motixafortide Peptide 1 mg/kg Subcutaneous
Subject Motixafortide Peptide 1.25 mg/kg Subcutaneous
Subject Motixafortide Peptide 1.5 mg/kg Subcutaneous
Subject Motixafortide Peptide 2 mg/kg Subcutaneous
Background Cytarabine Small molecule 1.5 g/kg Intravenous
Background Cytarabine Small molecule 3 g/kg Intravenous

Indications

acute myeloid leukemia