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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2014-002702-21
    Sponsor's Protocol Code Number:UKH062014
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-03-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-002702-21
    A.3Full title of the trial
    A double- blind, placebo controlled, randomized, multicenter, Phase II study to assess the efficacy of BL-8040 addition to consolidation therapy in AML patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test the effect of BL-8040 or placebo given to AML patients in addition to standard treatment in masked manner.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberUKH062014
    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 SponsorMartin-Luther-Universität Halle- Wittenberg
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioLineRX
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Halle
    B.5.2Functional name of contact pointPrincipial Investigator
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.4Telephone number00496221 56 8001
    B.5.5Fax number0049622156 5813
    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.3.2Product code BL-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 INNBL-8040
    D.3.9.1CAS number 664334-36-5
    D.3.9.2Current sponsor codeBL-8040
    D.3.9.3Other descriptive nameN-(4-Fluoro-benzoyl)-L-arginyl-L-arginyl-[L-3-(naphthyl)alanyl]-L-cysteinyl-L-tyrosyl-L-citrullinyl-L-lysyl-Dlysyl-L-prolyl-L-trosyl-L-arginyl-L-citrullinyl-L-cysteinyl-L-aginine amide, cyclic (4-13)-disulfide acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number73
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    consolidation therapy in acute myeloid leukemia in first complete remission
    E.1.1.1Medical condition in easily understood language
    patients with acute myeloid leukemia in first complete remission after induction therapy who are fit for intensive therapy and no allogeneic transplantation is provided.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare Relapse Free Survival (RFS) of subjects receiving BL-8040 compared to placebo, on top of standard consolidation therapy in subjects with AML
    E.2.2Secondary objectives of the trial
    • to compare overall survival (OS)
    • time to relapse in the treatment groups
    • to report RFS in the treatment groups at 6, 9, 12 and 18 months after randomization
    • to report relapse rates of the groups at 6, 9, 12 and 18 months after randomization
    • to compare RFS and OS of AML subjects between treatment groups in the two subgroups according to different cytogenetic and molecular risk
    • to report the Minimal residual disease (MRD; LSC rate) (by FACS at baseline, end of study treatment (EOT), 6, 9, 12 and study termination/early study termination visit (ST/EST) (month 18/EST)
    • to report RFS and OS in the two subgroups groups with/with no CXCR4 overexpression
    • to assess the toxicity, safety and tolerability of BL-8040 in combination with high-dose cytarabine
    • to report the incidence of Early Treatment termination
    • to report the incidence of Early Study termination (18 months)
    • to report the incidence of Early Treatment termination due to adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be at least 18 years old at the time of registration
    2. Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia).
    3. Subjects with AML who achieved complete remission (CR), including CRi and CRp after a maximum number of two cycles of induction chemotherapy (must contain at the minimum cytarabine as well as an anthracycline or mitoxantrone). CR (or CRi or CRp) needs to be confirmed by bone marrow aspirate up to 7 days prior to randomization.
    4. AML subjects younger than 60 yearswith intermediate or high-risk cytogenetics at the time of diagnosis
    5. 60 years old AML subjects and older at the time of diagnosis can be enrolled into the trial independent of cytogenetics or molecular genetic risk group.
    6. Subjects must provide written informed consent at screening, prior to performance any study-specific procedures or assessments which are not routinely performed for diagnosis or monitoring of AML, and the subjects must be willing to comply with treatment and to follow up assessments and procedures
    7. Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2 at screening
    8. The clinical laboratory values should be as follows (at screening):
    - WBC < 30.000/µl and > 1000/µl;
    - Platelets count > 70.000/µl
    - Creatinine < 1.0 mg/dl. If creatinine is between 1.0mg/dl and 1.3mg/dl, the creatinine clearance should be > 30ml/min as calculated using the Cockroft-Gault formula (See appendix 17.4)
    9. Women of child-bearing potential must practice an acceptable method of birth control until 6 month after the last dose of treatment was administered [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barriermethod (condom or diaphragm with spermicide)].
    Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
    A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide) or abstinence during the study.
    10. Subject is able and willing to comply with the requirements of the protocol
    E.4Principal exclusion criteria
    1. Relapsed or refractory AML
    2. Start of induction cycle > 90 days before randomization.
    3. Subjects who have received >2 cycles of induction chemotherapy for AML therapy.
    4. Subjects younger than 60 years with favorable cytogenetics (t(8;21) or inv(16) or t(16;16) or t(15;17)) or the confirmed presence of the resulting fusion protein AML1-ETO, CBFB-MYH11 or PML-RARA at the time of diagnosis .
    5. Subjects for which allogeneic HSCT is planned in CR1. If subject refuses HSCT, participation is allowed.
    6. Subjects planned for a further maintenance therapy after the end of the protocol defined consolidation therapy.
    7. Known allergic or hypersensitivity to BL-8040- or Cytarabine or to any of the test compounds, materials
    8. Use of investigational device or agents within 2 weeks or less than 5 half lifes for each investigational product /device at the time of enrollment. Subjects be treated with an experimental drug for two weeks before randomization. Subjects cannot take part in other clinical trials starting from screening. Registry studies / observational studies are permissible.
    9. Abnormal liver function tests:
    - Serum AST/ GOT or ALT/ GPT > 3x upper limit of normal (ULN)
    - Serum bilirubin: Total bilirubin > 2.0mg/dl or conjugated bilirubin > 0.8mg/dl
    10. O2 saturation < 92% (on room air)
    11. Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
    • Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, except in situ malignancy, or low-risk prostate, skin or cervical cancer after curative therapy. History of other cancer that according to the Investigator might confound the assessment of the endpoints of the study.
    • A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
    • History of any or more of the following cardiovascular conditions: cardiac angioplasty (within 6 months) or stenting (within 6 months) and/or myocardial infarction (MI) (within 6 months) or cerebro-vascular event within the past 6 months, unstable angina, vascular disease, class III or IV, congestive heart failure (as defined by the New York Heart Association (NYHA))• Known central nervous system disease that may jeopardize the subject’s study participation according to the investigator judgement
    • Active, uncontrolled infection.
    • The participation of subject´s receiving long acting insulin (with high protein binding) and oral antidiabetic agents should be weighed by the investigator due to increased susceptibility of hypoglycaemia. If such patients are enrolled, an increased frequency of blood glucose monitoring is required.
    12. Prior clinically significant grade 3-4 non-hematological toxicity to high-dose cytarabine or grade ≥ 2 of neurological toxicity
    13. Positive serology for HIV, active Hepatitis C and Hepatitis B (HBsAG pos.).Serology must be performed within 2 months before Randomization..
    14. Left ventricular ejection fraction (LVEF) of <40% by echocardiogram (ECHO) at screening.
    15. Subjects with psychological, psychiatric, neurological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Relapse Free Survival (RFS) time
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months after randomization
    E.5.2Secondary end point(s)
    - overall survival (OS)
    - time to relapse
    - RFS at 6, 9, 12 and 18 months after randomization
    - relapse at 6, 9, 12 and 18 months after randomization
    - Minimal residual disease (MRD) (by FACS at baseline, end of study treatment (EOT), 6, 9, 12 and study termination/early study termination visit (ST/EST) (month 18/EST)
    - toxicity, safety and tolerability of BL-8040 in combination with high-dose cytarabine
    - Early Treatment termination,
    - Early Study termination (18 months)
    - Early Treatment termination due to Adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    month 6, 9, 12 and 18 months after randomization
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    end of the trial is defined as the time point the data bank is locked, Justification for this definition: study- specific documentation has to be completed until this time-point
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state194
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 194
    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)
    not different from the expected normal treatment of that condition: bone marrow analysis every 3 months after end of consolidation therapy. In case of relapse further treatment depends on ivestigator´s choice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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