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

NCT03154827 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: BL-8040.AML.202
• Study Type: interventional
• Target: 1
• Locations: 6 countries
• Sites: 12

Brief Summary

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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Combination Treatment Single Arm

EXPERIMENTAL

Combination Treatment of BL-8040 with Atezolizumab

Drug: BL-8040; Drug: Atezolizumab

Interventions

BL-8040 DRUG

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.

Also known as: Motixafortide

Combination Treatment Single Arm

Atezolizumab DRUG

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.

Also known as: Tecentriq

Combination Treatment Single Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioLineRx, Ltd.: lead
• Genentech, Inc.: collaborator

Study Sites (12)

The University of Texas - Md Anderson Cancer Center - Leukemia Center

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Fakultni Nemocnice Brno / University Hospital Brno Interni Hematologicka A Onkologicka Klinika / Internal Hematology and Oncology Clinic

Brno, Czechia

Location

Fakultni Nemocnice Ostrava (Fno) / University Hospital Ostrava Klinika Hematoonkologie / Hematooncology Clinic

Ostrava, Czechia

Location

Fakultni Nemocnice Kralovske Vinohrady Fnkv / University Hospital Kralovske Vinohrady Interní Hematologická Klinika Fnkv / Internal Hematology Clinic

Prague, Czechia

Location

Rambam Medical Center

Haifa, Israel

Location

Shaarei Tzedek Medical Center

Jerusalem, Israel

Location

Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi

Lodz, Poland

Location

Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii

Bratislava, Slovakia

Location

Hospital San Pedro de Alcántara de Cáceres

Cáceres, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

4-fluorobenzoyl-TN-14003; atezolizumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: VP Clinical & Medical Affairs
• Organization: BioLineRx Ltd

clinicaltrials@biolinerx.com

+972-8-642-9100

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: January 8, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); SL (1); ES (3); US (2); PL (1); CZ (3)