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

BioLineRx, Ltd.12 sites in 6 countries1 target enrollmentJanuary 8, 2018

ConditionsAcute Myeloid Leukemia

InterventionsBL-8040 Atezolizumab

DrugsBL-8040 Atezolizumab

Overview

Phase: Phase 1
Intervention: BL-8040
Conditions: Acute Myeloid Leukemia
Sponsor: BioLineRx, Ltd.
Enrollment: 1
Locations: 12
Primary Endpoint: Relapse Free Survival
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

January 8, 2018

End Date

April 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BioLineRx, Ltd.

Responsible Party

Sponsor

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.