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    Summary
    EudraCT Number:2017-002237-29
    Sponsor's Protocol Code Number:BL-8040.AML.202
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-002237-29
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.4.1Sponsor's protocol code numberBL-8040.AML.202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioLineRx, Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioLineRx Limited
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioLineRx, Ltd.
    B.5.2Functional name of contact pointClinical Team Executive Assistant
    B.5.3 Address:
    B.5.3.1Street AddressModi’in Technology Park, 2 HaMa’ayan Street
    B.5.3.2Town/ cityModi’in
    B.5.3.3Post code7177871
    B.5.3.4CountryIsrael
    B.5.4Telephone number+9728642-9100
    B.5.5Fax number+9728642-9101
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBL-8040
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 664334-36-5
    D.3.9.2Current sponsor codeBL-8040
    D.3.9.3Other descriptive nameBKT140; 4F-benzoyl-TN14003
    D.3.9.4EV Substance CodeSUB187495
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number36.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAtezolizumab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typehumanized immunoglobulin (IgG1) monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the combination of BL-8040 and Atezolizumab prolongs the relapse free survival (RFS) time as compared to historical data.
    E.2.2Secondary objectives of the trial
    To demonstrate that the combination of BL-8040 and Atezolizumab reduces the Minimal Residual Disease (MRD) as compared to baseline.
    • To demonstrate that the combination of BL-8040 and Atezolizumab prolongs the Overall Survival (OS) time as compared to historical data.
    • To demonstrate that the combination of BL-8040 and Atezolizumab prolongs the Event Free Survival (EFS) time as compared to historical data.
    • To demonstrate that the combination of BL-8040 and Atezolizumab prolongs the time to first relapse as compared to historical data.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult men and women subjects aged ≥ 60 years.
    2. Confirmed diagnosis of AML (according to WHO criteria. See Appendix C)
    3. Subjects with newly diagnosed AML who have achieved Complete Remission (CR or CRi), after up to two cycles of induction chemotherapy.
    4. Subjects with intermediate I, II or adverse risk factors according to the ENL guidelines 2017.
    5. Induction therapy must have included cytarabine and may also have included an anthracycline or mitoxantrone.
    6. CR (or CRi) must be confirmed by bone marrow aspirate up to 21 days prior to enrollment.
    7. Subjects who have received 1-4 cycles of cytarabine-based consolidation therapy unless they have been deemed intolerant of consolidation therapy.
    8. Subjects who prior to screening are MRD positive according to local laboratory or with an unknown MRD status; are to be confirmed or tested, respectively, for MRD by central laboratory prior to enrollment.
    9. Subjects who are diagnosed with AML within one year prior to study enrollment.
    10. Subjects should have received the last dose of the last induction or consolidation treatment within 2 months prior to study enrollment
    11. Subjects who are not planned for allogeneic stem cell transplantation.
    12. Female subjects must be post-menopausal or of non-childbearing potential defined as absence of menses for > 1 year or those who have had a bilateral tubal ligation or hysterectomy.
    13. Male subjects with partners of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through at least 5 months after the last dose of study therapy. Examples of adequate methods are: for males-condom with or without spermicide, sexual abstinence or surgical sterility (vasectomy) or for female partners with childbearing potential –oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm.
    14. Subject is able and willing to comply with the requirements of the protocol.
    15. Subject is able to voluntarily provide written informed consent prior to the initiation of any screening or study-related procedures
    E.4Principal exclusion criteria
    1. Subjects diagnosed with acute promyelocytic leukemia.
    2. Subjects with extramedullary AML, including CNS involvement.
    3. Subjects who have achieved CR or CRi following treatment for relapsed or refractory AML after 2 inductions.
    4. Subjects in CR1 following autologous or allogeneic stem cell transplantation.
    5. Subjects who are candidates for allogenic stem cell transplantation and have a suitable donor.
    6. Subjects who have received treatment with hypomethylating agents for their AML, e.g., azacitidine and decitabine, etc.
    7. Life expectancy of ≤ 6 months.
    8. Clinically significant abnormal laboratory safety test values.
    9. Low Performance Status (ECOG > 2)
    10. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor alpha [anti−TNF-α] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.
    11. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment.
    12. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with Atezolizumab or within 5 months after the last dose of Atezolizumab
    13. Prior treatment with immune checkpoint blockade therapies (anti−CTLA-4, anti−PD-1, or anti−PD-L1) or immune agonists (anti-CD137, anti-CD40, anti-OX40).
    14. Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product.
    15. Use of investigational device or drug within 2 weeks or five half-lives, whichever is longer, prior to the enrolment date.
    16. Past or current history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune myocarditis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, or multiple sclerosis.
    17. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    18. Presence of active, uncontrolled infection or any serious infection including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia requiring hospitalization.
    19. Treatment with IV antibiotics within 14 days prior to baseline. Subjects on prophylactic antibiotics, antifungals and antivirals, e.g., to prevent a urinary tract infection, chronic obstructive pulmonary disease exacerbation or due to prolonged neutropenia in the absence of documented infection will be considered eligible.
    20. Subjects with history of organ or stem cell transplantation.
    21. Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, fatty liver disease and inherited liver disease.
    22. Active tuberculosis.
    23. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, or unstable arrhythmia or unstable angina within 3 months prior to initiation of study treatment.
    24. Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment.
    25. Positive HIV test at screening or at any time prior to screening.
    26. Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study.
    27. Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
    28. Subjects with concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk.
    E.5 End points
    E.5.1Primary end point(s)
    Time from CR to occurrence of earlier relapse or death from any cause (RFS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Depending upon occurence. Study duration will not exceed 4.5 years.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    • Change from baseline to Cycles 3, 9, 17 and 34 in MRD status measured using quantitative, multi-color, flow cytometry.
    • Time from 1st study drug administration to death from any cause (OS).
    • Event Free Survival (EFS) measured as the earlier from 1st study drug administration to the date of primary refractory disease, or relapse from CR, or death from any cause from 1st study drug administration.
    • Time from CR to first relapse (TTR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending upon occurence. Study duration will not exceed 4.5 years.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Therapeutic exploratory
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    Hungary
    Israel
    Poland
    Slovakia
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study duration will not exceed 4.5 years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-10-31
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