Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

August 14, 2024 updated by: BioLineRx, Ltd.

An Open-Label, Single Arm, 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

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- The BATTLE Study

The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia.

Additional objectives are:

Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combination Treatment Single Arm
Combination Treatment of BL-8040 with Atezolizumab
Drug: BL-8040
Subjects will receive maintenance treatment consisting of 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.
Other Names:
  • Motixafortide
Drug: Atezolizumab
Subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 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.
Other Names:
  • Tecentriq

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relapse Free Survival
Time Frame: 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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioLineRx, Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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