Clinical Trials /

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 Who Are 60 Years or Older - The BATTLE Study

NCT03154827

Description:

This study will test the safety and effectiveness of a combination of investigational new drug called BL-8040 and atezolizumab to find out what effects, good or bad, this treatment has on medical condition. Atezolizumab is manufactured by Roche and is approved by FDA for other indications while BL-8040 is in late stages of clinical development. This is an investigational study. Approximately 60 patients will take part at multiple centers worldwide. It is an open-label study, which means that both subjects and the doctors will know which treatment you are receiving. All participants in the study will receive the investigational drug, BL-8040, both alone and in combination with atezolizumab. In other words, there will be no placebo (dummy drug). 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

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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 Who Are 60 Years or Older - The BATTLE Study
  • Official Title: 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 Who Are 60 Years or Older - The BATTLE Study

Clinical Trial IDs

  • ORG STUDY ID: BL-8040.AML.202
  • NCT ID: NCT03154827

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
BL-8040Combination Treatment Single Arm
AtezolizumabTecentriqCombination Treatment Single Arm

Purpose

This study will test the safety and effectiveness of a combination of investigational new drug called BL-8040 and atezolizumab to find out what effects, good or bad, this treatment has on medical condition. Atezolizumab is manufactured by Roche and is approved by FDA for other indications while BL-8040 is in late stages of clinical development. This is an investigational study. Approximately 60 patients will take part at multiple centers worldwide. It is an open-label study, which means that both subjects and the doctors will know which treatment you are receiving. All participants in the study will receive the investigational drug, BL-8040, both alone and in combination with atezolizumab. In other words, there will be no placebo (dummy drug). 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

Trial Arms

NameTypeDescriptionInterventions
Combination Treatment Single ArmExperimentalCombination Treatment of BL-8040 with Atezolizumab
  • BL-8040
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

        AML confirmed subjects aged ≥ 60 years who have achieved complete remission (CR or CRi)
        after induction/consolidation Ara-C based therapy, that have MRD positive status and are
        not planned for stem cell transplantation.

        Exclusion Criteria:

        Subjects diagnosed with acute promyelocytic leukemia or with extramedullary AML or subjects
        who have achieved CR or CRi following treatment for AML. Subjects who have received
        treatment with hypomethylating agents.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse Free Survival
Time Frame:Up to 5 years
Safety Issue:
Description:Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BioLineRx, Ltd.

Last Updated

July 9, 2018