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

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

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Drug: BL-8040; Drug: Atezolizumab

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
    • Fakultni Nemocnice Brno / University Hospital Brno Interni Hematologicka A Onkologicka Klinika / Internal Hematology and Oncology Clinic
  • Ostrava, Czechia
    • Fakultni Nemocnice Ostrava (Fno) / University Hospital Ostrava Klinika Hematoonkologie / Hematooncology Clinic
  • Praha, Czechia
    • Fakultni Nemocnice Kralovske Vinohrady Fnkv / University Hospital Kralovske Vinohrady Interní Hematologická Klinika Fnkv / Internal Hematology Clinic
• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Jerusalem, Israel
    • Shaarei Tzedek Medical Center
• Poland
  • Łódź, Poland
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
• Slovakia
  • Bratislava, Slovakia
    • Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii
• Spain
  • Caceres, Spain
    • Hospital San Pedro de Alcántara de Cáceres
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain
    • Hospital Universitario La Fe de Valencia
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas - Md Anderson Cancer Center - Leukemia Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin/Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Treatment Single Arm; Combination Treatment of BL-8040 with Atezolizumab	Drug: BL-8040; Subjects will receive once daily SC injections of 1.25 mg/kg of BL-8040 on the first 3 days of each cycle.; Drug: Atezolizumab; Subjects will receive Atezolizumab 1200 mg by IV infusion on Day 2 of every cycle.; Other Names: Tecentriq

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioLineRx, Ltd.
• Collaborators: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Antineoplastic Agents; Atezolizumab
• Other Study ID Numbers: BL-8040.AML.202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No