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
Additional locations may be listed on ClinicalTrials.gov for NCT03154827.
See trial information on ClinicalTrials.gov for a list of participating sites.
This study will assess the safety and effectiveness of a combination of BL-8040 and
atezolizumab to find out what is the Safety, Tolerability and Efficacy of this treatment
combination for maintenance treatment in subjects with acute myeloid leukemia.
This is a single arm, open label, Phase Ib/II study in which eligible subjects will
receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on
Day 2 of each 21-day cycle and subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3
of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34
treatment cycles), until early discontinuation for any reason or until disease relapse,
whichever comes first.
Approximately 60 patients will take part at multiple centers worldwide.
The duration of the treatment period of the study will be up to 2 years and will be
followed by one year safety follow up. The study will consist of:
- a screening period of 21 days to allow your doctor to assess your suitability for
enrollment into the study
- a treatment period of combination regimen of 21 day cycles for up to 2 years
- a follow-up period of up to 30 days after completion of combined treatment with
BL-8040 + Atezolizumab
- an additional follow up period for up to one year after the completion of the
treatment
Lead OrganizationBioLineRx Limited