drugset / Trial / NCT03154827

Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

NCT03154827

Phase 1/2 Terminated 1 enrolled BioLineRx, Ltd. Genentech, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia. Additional objectives are: Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance

Timeline

Start
2018-01-08
Primary completion
2020-04-01
Completion
2020-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody Intravenous
Subject Motixafortide Peptide Subcutaneous