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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

Sponsor
BioLineRx, Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03154827
Collaborator
Genentech, Inc. (Industry)
1
Enrollment
12
Locations
1
Arm
26.7
Actual Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 8, 2018
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relapse Free Survival [Up to 5 years]

      Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas - Md Anderson Cancer Center - Leukemia Center Houston Texas United States 77030
    2 Medical College of Wisconsin/Froedtert Hospital Milwaukee Wisconsin United States 53226
    3 Fakultni Nemocnice Brno / University Hospital Brno Interni Hematologicka A Onkologicka Klinika / Internal Hematology and Oncology Clinic Brno Czechia
    4 Fakultni Nemocnice Ostrava (Fno) / University Hospital Ostrava Klinika Hematoonkologie / Hematooncology Clinic Ostrava Czechia
    5 Fakultni Nemocnice Kralovske Vinohrady Fnkv / University Hospital Kralovske Vinohrady Interní Hematologická Klinika Fnkv / Internal Hematology Clinic Praha Czechia
    6 Rambam Medical Center Haifa Israel
    7 Shaarei Tzedek Medical Center Jerusalem Israel
    8 Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi Łódź Poland
    9 Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii Bratislava Slovakia
    10 Hospital San Pedro de Alcántara de Cáceres Caceres Spain
    11 Hospital Universitario 12 de Octubre Madrid Spain
    12 Hospital Universitario La Fe de Valencia Valencia Spain

    Sponsors and Collaborators

    • BioLineRx, Ltd.
    • Genentech, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioLineRx, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03154827
    Other Study ID Numbers:
    • BL-8040.AML.202
    First Posted:
    May 16, 2017
    Last Update Posted:
    May 18, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Atezolizumab

    Study Results

    No Results Posted as of May 18, 2020