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

Stopped early · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT03154827

Run by

BioLineRx, Ltd.

People needed

1

Starts

2018-01-08

Expected to finish

2020-04-01

Last updated by the study team

2024-09-05

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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