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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

January 8, 2018

Primary Completion Date

April 1, 2020

Study Completion Date

April 1, 2020

Conditions
Acute Myeloid Leukemia
Interventions
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.

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.

Trial Locations (12)

53226

Medical College of Wisconsin/Froedtert Hospital, Milwaukee

77030

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

Unknown

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

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

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

Rambam Medical Center, Haifa

Shaarei Tzedek Medical Center, Jerusalem

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

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

Hospital San Pedro de Alcántara de Cáceres, Cáceres

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Fe de Valencia, Valencia

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

BioLineRx, Ltd.

INDUSTRY

NCT03154827 - Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter