Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | Intravenous |
| Subject | Motixafortide | Peptide | — | Subcutaneous |