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    The EU Clinical Trials Register currently displays   42159   clinical trials with a EudraCT protocol, of which   6934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004674-17
    Sponsor's Protocol Code Number:NL59901.078.17
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-06-11
    Trial 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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-004674-17
    A.3Full title of the trial
    A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.
    Pilotní studie testující proveditelnost, bezpečnost a účinnost přidání BiTE protilátky blinatumomab do léčebného protokolu Interfant-06 u kojenců s akutní lymfoblastickou leukémií s přestavbou genu MLL.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blinatumomab in infant ALL
    Blinatumomab u kojenců s ALL
    A.4.1Sponsor's protocol code numberNL59901.078.17
    A.5.4Other Identifiers
    Name:TrialregisterNumber:NL5993(=NTR6359)
    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 SponsorPrincess Máxima Center for Pediatric Oncology
    B.1.3.4CountryNetherlands
    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 supportGo4Children
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMammoet B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrincess Máxima Center for Pediatric Oncology
    B.5.2Functional name of contact pointTrialmanager DCOG-ECTC
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 25
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 Cs
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031889727272
    B.5.5Fax number0031889729009
    B.5.6E-mailc.m.zwaan@prinsesmaximacentrum.nl
    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 Yes
    D.2.1.1.1Trade name Blincyto
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameBlincyto
    D.3.2Product code AMG103
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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 Yes
    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 typeimmunotherapy
    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 Lymphoblastic Leukemia
    E.1.1.1Medical condition in easily understood language
    Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic 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 assess the safety of 1 course of blinatumomab added to the Interfant-06 backbone in infants with newly diagnosed ALL.
    E.2.2Secondary objectives of the trial
    - to assess the feasibility of adding 1 course of blinatumomab to the Interfant-06 backbone
    - to define the preliminary response rate of this regimen
    - to assess pharmacokinetics of blinatumomab in infants
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must be treated according to Interfant-06 backbone
    2. Patients must have newly diagnosed, CD19 positive, B-precursor acute lymphoblastic leukemia
    3. Morphological verification of the diagnosis, confirmed with immunophenotyping
    4. < 365 days of age at time of diagnosis of ALL
    5. > 28 days of age at start of blinatumomab administration
    6. MR and HR patients according to risk stratification of the Interfant-06 protocol (see table 1), thus including all MLL-rearranged and MLL not-evaluable patients (these latter are stratified and treated according to MR).
    7. M1 or M2 bone marrow after induction (~day 33).
    If the peripheral blood shows pancytopenia at day 33 it is justified to postpone the bone marrow puncture according to the Interfant-06 protocol. If the bone marrow at day 33 is hypocellular and one is therefore unable to determine M1 or M2 status, then the bone marrow puncture should be repeated.
    8. Written informed consent from parents or guardians
    E.4Principal exclusion criteria
    1. Biphenotypic ALL
    2. Mature B-ALL
    3. Presence of t(9;22) (q34;q11) or BCR-ABL fusion transcript
    4. M3 marrow after induction
    5. Patients with Down syndrome (because of increased toxicity of conventional chemotherapy)
    6. Clinically relevant CNS pathology requiring treatment (eg unstable epilepsy)
    7. Evidence of CNS involvement of ALL (CNS2 or CNS3) at the end of induction. Subjects with CNS disease at the time of diagnosis are eligible if a CNS1 status is obtained prior to enrolment (lumbar puncture at ~day 29 of induction, see definitions CNS status in Appendix D)
    8. Known infection with human immunodeficiency virus (HIV)
    9. Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing

    Exclusion criteria before start (-d3) of blinatumomab:
    1. Peripheral neutrophils <0.5 x 109/l and WBC < 2 x 109/l (for M1 marrow only, with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
    2. Peripheral platelets < 50 x 109/L (for M1 marrow only with a maximum delay of 2 weeks. Patients with M2 bone marrow will not recover their blood counts and can start as soon as the other inclusion criteria are met)
    3. Creatinine > 1.5 X ULN, based on the normal ranges for age and gender of the local laboratories
    4. Total bilirubin > 3 x ULN unless the patient has documented Gilbert Syndrome
    5. Chemotherapy related toxicities that have not resolved to < grade 2
    6. Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of clinically relevant toxicities defined as any toxicity that is possibly or definitely attributable to blinatumomab AND results in permanent discontinuation of blinatumomab OR death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously through treatment and safety follow-up
    E.5.2Secondary end point(s)
    Toxicity/feasibility:
    1. Incidence and severity of (serious) adverse events, independently to relationship with blinatumomab
    2. Number of treatment interruptions due to toxicity occurring during blinatumomab
    3. Proportion of patients that receive a full course (4 weeks) of blinatumomab
    4. Incidence and severity of key safety parameters till start of maintenance and during long-term follow-up
    Activity/Efficacy:
    5. MRD response at the following time-points: TP2 d33 (end of induction), TPblina1 d15 (after initial 15 days of blinatumomab) and TPblina2 d29 (after the complete course of blinatumomab)
    6. MRD response at the following time-points: TP2 d33 (end of induction) and TP4 (end of Protocol IB)
    7. Proportion of MR patients with MRD > 5x10-4 before OCTADAD (indication for SCT)
    8. cCR/CR and 6 months post-induction EFS and the long-term EFS and OS
    Pharmacokinetics:
    9. Steady state concentration of blinatumomab (Css)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously through treatment and safety follow-up
    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 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.7.1.3.1Other 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Australia
    Austria
    Belgium
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Netherlands
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 30
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 30
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Interfant study group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-12-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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