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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03154827
• Other study ID #: BL-8040.AML.202
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 8, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• BL-8040
Subjects will receive once daily SC injections of 1.25 mg/kg of BL-8040 on the first 3 days of each cycle.
• Atezolizumab
Subjects will receive Atezolizumab 1200 mg by IV infusion on Day 2 of every cycle.

Locations

Country	Name	City	State
Czechia	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
Israel	Rambam Medical Center	Haifa
Israel	Shaarei Tzedek Medical Center	Jerusalem
Poland	Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi	Lódz
Slovakia	Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii	Bratislava
Spain	Hospital San Pedro de Alcántara de Cáceres	Caceres
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Fe de Valencia	Valencia
United States	The University of Texas - Md Anderson Cancer Center - Leukemia Center	Houston	Texas
United States	Medical College of Wisconsin/Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
BioLineRx, Ltd.	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Israel,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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