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Trial record 1 of 1 for:    BL-8040.AML.202
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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

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ClinicalTrials.gov Identifier: NCT03154827
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: BL-8040 Drug: Atezolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : March 17, 2021
Estimated Study Completion Date : March 17, 2022


Arm Intervention/treatment
Experimental: Combination Treatment Single Arm
Combination Treatment of BL-8040 with Atezolizumab
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.

Drug: Atezolizumab
Subjects will receive Atezolizumab 1200 mg by IV infusion on Day 2 of every cycle.
Other Name: Tecentriq




Primary Outcome Measures :
  1. Relapse Free Survival [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154827


Contacts
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Contact: Yelena Sigal +972-549083598 yelenas@biolinerx.com

Locations
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United States, Texas
The University of Texas - Md Anderson Cancer Center - Leukemia Center Recruiting
Houston, Texas, United States, 77030
Contact: Jorge Cortes, MD    713-794-5783    jcortes@mdanderson.org   
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Laura Michaelis, MD    414-805-1118    lmichaelis@mcw.edu   
Czechia
Fakultni Nemocnice Brno / University Hospital Brno Interni Hematologicka A Onkologicka Klinika / Internal Hematology and Oncology Clinic Recruiting
Brno, Czechia
Contact: Jiri Mayer, MD    42053223 2144    mayer.jiri@fnbrno.cz   
Fakultni Nemocnice Ostrava (Fno) / University Hospital Ostrava Klinika Hematoonkologie / Hematooncology Clinic Recruiting
Ostrava, Czechia
Contact: Roman Hajek, MD    420597372088    roman.hajek@fno.cz   
Fakultni Nemocnice Kralovske Vinohrady Fnkv / University Hospital Kralovske Vinohrady Interní Hematologická Klinika Fnkv / Internal Hematology Clinic Recruiting
Praha, Czechia
Contact: Jan Novak, MD    420597372091    novakjan@centrum.cz   
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Yishai Ofran, MD         
Shaarei Tzedek Medical Center Recruiting
Jerusalem, Israel
Contact: Jacob Rowe, MD         
Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi Recruiting
Łódź, Poland
Contact: Tadeusz Robak, MD         
Slovakia
Národný Onkologický Ústav / National Cancer Institute, Oddelenie Onkohematológie Ii / Department of Oncohematology Ii Recruiting
Bratislava, Slovakia
Contact: Iveta Oravkova, MD    +421 2 59378 490    Iveta.Oravcova@nou.sk   
Spain
Hospital San Pedro de Alcántara de Cáceres Recruiting
Caceres, Spain
Contact: Juan Bergua, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Pillar Martinez, MD         
Hospital Universitario La Fe de Valencia Recruiting
Valencia, Spain
Contact: Pau Montesinos, MD         
Sponsors and Collaborators
BioLineRx, Ltd.
Genentech, Inc.

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Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT03154827     History of Changes
Other Study ID Numbers: BL-8040.AML.202
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs