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
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
Interventions
Drug | Synonyms | Arms |
---|
BL-8040 | | Combination Treatment Single Arm |
Atezolizumab | Tecentriq | Combination 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
Name | Type | Description | Interventions |
---|
Combination Treatment Single Arm | Experimental | Combination Treatment of BL-8040 with 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: | Terminated |
Lead Sponsor: | BioLineRx, Ltd. |
Last Updated
May 18, 2020