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
- Registration Number
- NCT03154827
- Lead Sponsor
- BioLineRx, Ltd.
- 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
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Treatment Single Arm BL-8040 Combination Treatment of BL-8040 with Atezolizumab Combination Treatment Single Arm Atezolizumab Combination Treatment of BL-8040 with Atezolizumab
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Medical College of Wisconsin/Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
The University of Texas - Md Anderson Cancer Center - Leukemia Center
🇺🇸Houston, Texas, 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
🇨🇿Praha, Czechia
Shaarei Tzedek Medical Center
🇮🇱Jerusalem, Israel
Hospital San Pedro de Alcántara de Cáceres
🇪🇸Caceres, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Fe de Valencia
🇪🇸Valencia, Spain
Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii
🇸🇰Bratislava, Slovakia
Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi
🇵🇱Łódź, Poland
Rambam Medical Center
🇮🇱Haifa, Israel